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EC number: 247-094-1 | CAS number: 25550-51-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
A screening study according to OECD 421 with the read-across substance, 4 -MHHPA, showed no adverse effects on fertility. The NOAEL was determined to be 450 mg/kg bw/d.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 450 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Well described GLP compliant study conducted to recognized international test guidelines.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data were available on effects on fertility of MHHPA, instead, read across approach was applied using data from the structural analogue 4-MHHPA as similar chemical and toxicological properties are assumed.
The effects hexahydro-4 methylphthalic anhydride (4-MHHPA) on fertility, pregnancy and early lactation of the offspring have been investigated in a reproduction/developmental toxicity screening study conducted according to OECD test methods. Groups of rats were dosed by oral gavage at levels of 50, 150 and 450 mg/kg/day. Males were treated for 2 weeks prior to pairing and during pairing of all females until the day before necropsy, for a total of 6 weeks. Females were treated for 2 weeks prior to pairing, during pairing and throughout the gestation and lactation periods and for 4 days post partum. No significant changes and no treatment-related effects were detected in males and females during thein vivophase. Reproductive parameters such as fertility index, pre-coital interval and copulatory index did not show significant differences in treated groups compared to controls. Gestation length, litter data, sex ratios and implantation losses (pre and post) were unaffected by treatment. Findings at macroscopic and microscopic examinations, in both males and females, did not reveal differences between groups that could be related to treatment. On the basis of these findings, 450 mg/kg/day is considered to be the No Observed Adverse Effect Level (NOAEL). This study is acceptable and satisfies the guideline requirement for a reproduction and developmental toxicity screening study in rats (OECD 421).
A "higher tier" study such as the OECD 443 EOGRTS is currently ongoing and the dossier will be updated as these results become available.
The available data for structural homologues of MHHPA and 4-MHHPA indicate neither potential for teratogenic effects nor for reproduction toxicity in different species. These data together with the ongoing OECD 443 study will allow a scientific validated evaluation of the respective endpoints.
Effects on developmental toxicity
Description of key information
Based on a prenatal developmental toxicity study according to OECD 414 with the read-across substance 4-MHHPA in rats, the NOAEL is considered to be 460 mg/kg/day for developmental toxicity.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to IUCLID Section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 460 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- mortality
- pre and post implantation loss
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: No test item related adverse effect on the fetuses were observed.
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 615 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 460 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Well described GLP compliant study conducted to recognized international test guidelines.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data were available on effects on the developmental toxicity of MHHPA, instead, a read across approach was applied using data from the structural analogue 4-MHHPA as similar chemical and toxicological properties are assumed.
Key study:
OECD 414 (2021)
The structural analogue hexahydro-4-methylphthalic anhydride (4-MHHPA) was examined for its possible prenatal developmental toxicity in a study according to OECD 414. Groups of 28 to 30 sperm-positive female Han: of Wistar origin rats were treated with 4-MHHPA by oral administration daily at three dose levels of 460, 615 and 800 mg/kg bw/day respectively from day 5 up to and including day 19 post coitum. A control group of 28 sperm positive females was included and the animals were given the vehicle sunflower oil. The treatment volume was 4 mL/kg bw. A sufficient stability and homogeneity in the chosen vehicle were verified over the range of relevant concentrations at the appropriate frequency of preparation. The test item in sunflower oil was stable at room temperature for at least one day and for three days in the refrigerator (5 ± 3 °C) at the concentrations of 1 and 280 mg/g. Analytical control of dosing solutions was performed during the first and last week of treatment. Concentrations of the test item in the dosing formulations varied in the acceptable range between 91 and 105 % of nominal concentrations at both analytical occasions confirming proper dosing. During the study, mortality was checked and clinical observations were performed. Body weight and food consumption of the dams were also recorded. The day, when sperm was detected in the vaginal smear, was regarded as day 0 of gestation. Blood sampling for determination of thyroid hormones FT3 and FT4 as well as TSH, Caesarean section and gross pathology were performed on gestational day 20. Thyroids were weighed and evaluated histologically. The number of implantations, early and late resorptions, live and dead fetuses in each uterine horn and the number of corpora lutea were recorded. Each fetus was weighed and examined for sex and gross external abnormalities. The placentas were weighed and examined externally. External fetal sex was determined by gross pathological examination and compared with internal (gonadal) sex in all fetuses (examined for both skeletal and soft tissue alterations). The anogenital distance was measured. In addition, indication of incomplete testicular descent / cryptorchidism was noted in male fetuses. About half of each litter was preserved for visceral examination and the other half of the litters were preserved for skeletal evaluation. At visceral examination the bodies were micro dissected by means of a dissecting microscope. The heads were examined by Wilson's free-hand razor blade method. After cartilage-bone staining the skeletons were examined by means of a dissecting microscope. All abnormalities found during the fetal examinations were recorded.
In total, on gestation day 20 there were 23, 21, 19 and 20 evaluated litters in the control, 460, 615 and 800 mg/kg bw/day groups, respectively. One female died in the course of the study in the 800 mg/kg bw/day group due to an effect of the test item after clinical signs such as hunched back, piloerection and reduced activity and digging in the bedding in the days before. Necropsy revealed macroscopic changes in the lungs, liver and ileum. Histopathology supported these findings and additionally there were lesions in the heart observed. Similar test item related clinical signs were observed in the 800 and 615 mg/kg bw/day group. Reduced food consumption and lower body weight gain (including corrected body weight gain in the 800 mg/kg bw/day dose group) was observed in the 800 and 615 mg/kg bw/day group which was attributed to an effect of the test item. Slight reductions in the food consumption of the 460 mg/kg bw/day group animals were not considered as adverse. There were no significant differences in the body weight (including corrected body weight) of the dams. Lower values compared to control were measured in all dose groups (in similar manner) for the free thyroid hormone level FT4. The FT3 values were also statistically significantly lower in the 615 and 460 mg/kg bw/day groups. In the absence of a dose-response relationship and since the values were within the value of the historical control data these findings are considered not test-item related. The TSH hormone levels were similar in all groups. There were no test item related differences in thyroid weight among the dosing groups. The treatment did not result in histological changes of the thyroid gland in any of the dose groups. Slight increase of post-implantation loss (early and late resorptions) including the occurrence of total post-implantation loss in one female both in the 800 and 615 mg/kg bw/day group were likely attributed to an effect of the test item, possibly due to maternal toxicity. The fetal weight was slightly lower and the incidence of growth retarded fetuses was higher in the 800 and 615 mg/kg bw/day groups (at a similar level), however statistical analysis revealed no significance. Hence, a test item effect was not proved. There were no significant differences in the ano-genital distance and placental weight parameters. At fetal examinations, there were no significant differences in the incidence of malformations at any dose level. There were no malformed fetuses found on external examination. In one litter, the placentas were observed as larger and or with wider margin in the 800 mg/kg bw/day group. Considering the lack of dose response or the low incidences, the visceral variations observed were not attributed to treatment. Two single cases of brain malformations such as an external hydrocephaly and a hole in the thalamus region in the dose groups of 800 and one 615 mg/kg bw/day group were considered incidental and toxicologically not relevant. Some increases in delayed ossifications might be related to maternal toxicity in the 800 and 615 mg/kg bw/day groups. Slightly bent scapula occurred in the test item treated groups with low incidences (1 to 3 fetuses per dose group) and two fetuses of one litter had bent scapula (one with slightly thicker humerus) in the 800 mg/kg bw/day group (latter in the litter with placenta alterations). Slightly bent or bent scapula as well as malformed humerus may occur in control fetuses according to the background data (laboratory's HCD: slight wavy ribs: 16.1%), hence a test item response was not proved.
In conclusion the oral treatment of pregnant Han: Wistar rats from gestation day 5 up to day 19 (the day before Caesarean section) with 4-MHHPA at the dose level of 800 mg/kg bw/day caused test-item related death of one animal. Clinical signs of animals in the 800 and 615 mg/kg bw/day groups were attributed to the treatment. The treatment with the test item caused reduced food consumption and body weight gain in the 615 and 800 mg/kg bw/day groups. Besides a significantly decreased corrected body weight gain in the 800 mg/kg bw/day group no significant differences in the body weight/corrected body weight values were detected. Thyroid-related parameters (FT3, FT4 TSH, weight, histopathology) were not affected by treatment. The slightly but statistically significantly increased postimplantation loss in the 615 and 800 mg/kg bw/day group is considered to be treatment-related. Although the incidence of body weight retarded fetuses was slightly increased in the mid and high dose group, there were no statistically significant differences in the mean body weight of the fetuses. No statistically significant differences in the incidence of malformations over all dosing groups were observed. Based on the observations the No Observed Adverse Effect Level (NOAEL) was determined as to be 460 mg/kg bw/day for maternal toxicity and developmental toxicity including teratogenicity.
Supporting studies:
OECD 414 (2018)
The structural analogue hexahydro-4-methylphthalic anhydride (4-MHHPA) was examined for its possible prenatal developmental toxicity in a GLP compliant study according to OECD 414. Groups of 26 sperm-positive female Hsd. Han: Wistar rats were treated with the test item by oral administration daily at three dose levels of 80, 240 and 460 mg/kg bw/day respectively from day 5 up to and including day 19 post coitum. A control group of 26 sperm positive females was included and the animals were given the vehicle sunflower oil. The treatment volume was 4 mL/kg bw. Concentrations of the test item in the dosing formulations varied in the acceptable range between 99 and 109 % of nominal concentrations at both analytical occasions confirming proper dosing. During the study, mortality was checked and clinical observations were performed. The body weights and food consumption of the dams were also recorded. The day when sperm was detected in the vaginal smear was regarded as day 0 of gestation. Caesarean section and gross pathology were performed on gestational day 20. The number of implantations, early and late resorptions, live and dead fetuses in each uterine horn and the number of corpora lutea were recorded. Each fetus was weighed and examined for sex and gross external abnormalities. The placentas were weighed and examined externally. About half of each litter was preserved for visceral examination and the other half of the litters were preserved for skeletal evaluation. At visceral examination the bodies were micro dissected by means of a dissecting microscope. The heads were examined by Wilson's free-hand razor blade method. After cartilage-bone staining the skeletons were examined by means of a dissecting microscope. All abnormalities found during the fetal examinations were recorded. In total, on gestation day 20 there were 20, 19, 21 and 17 evaluated litters in the control, 80, 240 and 460 mg/kg bw/day group respectively. None of the females died before scheduled necropsy and there were no test item related clinical signs recorded in all dose groups. No treatment related necropsy findings were observed. There were no treatment related changes in food consumption or body weights indicated. The number of implantations, intrauterine mortality and sex distribution of the fetuses were not influenced by the treatment. There were no test item related adverse effects on the fetal weight, external and visceral development of fetuses. There were no test item related malformations found. Based on these observations the No Observed Adverse Effect Level (NOAEL) for both maternal and developmental toxicity (including teratogenicity) was 460 mg/kg bw/day.
DRF (2021)
The structural analogue hexahydro-4-methylphthalic anhydride (4-MHHPA) was examined for its possible prenatal developmental toxicity in a dose range finding study. Groups of eleven to twelve spermium-positive female Han: WIST rats were treated with the test item by oral administration daily at three dose levels of 500, 700 and 900 mg/kg bw/day respectively from day 5 up to and including day 19 post coitum. A control group of eleven spermium positive females was included and the animals were given the vehicle sunflower oil. The treatment volume was 4 mL/kg bw. During the study, mortality was checked and clinical observations were performed. Body weight and food consumption of the dams were also recorded. The day, when spermium was detected in the vaginal smear, was regarded as day 0 of gestation. Caesarean section and gross pathology were performed on gestational day (g.d.) 20. The number of implantations, early and late resorptions, live and dead fetuses in each uterine horn and the number of corpora lutea were recorded. Each fetus was weighed and examined for sex and gross external abnormalities. The placentas were examined externally.
On gestation day 20, a total of 10, 9, 11 and 6 litters in the control, 500, 700 and 900 mg/kg bw/day groups, respectively, were evaluated. The dose level of 900 mg/kg bw/day caused death of three dams. One dam died after five, one after six and one after fourteen administrations. Reduced activity and piloerection were recorded for the animals that died and in addition in two females that survived (one with total post-implantation loss and one non-pregnant) in the 900 mg/kg bw/day group. Laying down and dyspnoe was recorded for one female which died. Digging in the bedding after treatment and salivation was observed in all test item treated groups. All of the three animals which died before scheduled necropsy had dark red liver. Bloody or yellow or yellowish-brownish content in the intestines or yellow dilute or whitish content in the stomach was recorded for the animals that died and for the surviving female with total post-implantation loss in the 900 mg/kg bw/day group. Sporadically gas filled intestine segments were observed in the animals in the 900 and 500 mg/kg bw/day group. In one high dose animal which died reddish mottled lungs were found. Slight to moderately lower mean food consumption of the dams was indicated, most notable between g.d. 5 and 11, in the 900 mg/kg bw/day group. In the 700 mg/kg bw/day dose group the average food consumption was slightly lower between g.d. 5 and 11. This was not unambiguously attributed to the test item. Slightly lower body weight was observed in the 900 and 700 mg/kg bw/day group, in the latter not proved to be due to the test item. Differences were more notable in regard to lower body weight gain values in the 900 mg/kg bw/day dose group and also observed in the 700 mg/kg bw/day dose group. In the 700 mg/kg bw/day dose group this effect was less pronounced. The slightly lower body weight gain in the 500 mg/kg bw/day between g.d. 5 and 8 was not proved to be due to the test item. The corrected body weight gain was lower in the 700 and 900 mg/kg bw/day group with a dose dependent response. There was no dose response indicated in the mean percent of early embryonic death. The percentage of late embryonic death increased slightly and the average fetal death increased due to one female with total post-implantation loss in the 900 mg/kg bw/day group. There was no test item effect indicated in the number of implantations or percent pre-implantation loss. The number of viable fetuses was slightly to moderately lower in the 700 and 900 mg/kg bw/day group, not proved to be due to the test item at 700 mg/kg bw/day. Slightly lower fetal weight in the 900 mg/kg bw/day group and in case of female fetuses in the 700 mg/kg bw/day group was not considered as significant. There were no malformations or placental alterations found. There was no test item effect indicated in incidence of variations i.e. growth retardations.
In the present dose range finding study, oral treatment of pregnant Han: WIST rats with the dose level of 900 mg/kg bw/day of the test item caused death of three dams and clinical signs such as reduced activity, piloerection, laying, dyspnoe and salivation of the animals. The test item caused moderate reduction in the food consumption and lower body weight parameters at 900 mg/kg bw/day (including a minimal weight loss between g.d. 5 and 8 and a moderately lower corrected body weight gain). Less significantly lower food consumption and body weight parameters including corrected body weight gain at 700 mg/kg bw/day were not unambiguously attributed to an effect of the test item. The increase of fetal death in the 900 mg/kg bw/day dose group due to one female with total post-implantation loss and moderately lower mean number of viable fetuses was considered treatment related, most likely secondary to the severe maternal toxicity demonstrated by the strong clinical symptoms. The mean number of implantations, percentage preimplantation loss, early and late resorptions were not proved to be affected by the test item. Slightly lower body weight of fetuses was not proved to be due to the treatment with the test item. The test item caused neither malformations, nor increase of fetal variations or placental abnormalities. Based on the observations the dose range finding study determined the doses of 460, 615 and 800 mg/kg bw/d for the main study (OECD 414 (2021)). The No Observed Adverse Effect Level (NOAEL) was considered to be 500 mg/kg bw/d for maternal toxicity and developmental toxicity.
DRF (2018)
The structural analogue hexahydro-4-methylphthalic anhydride (4-MHHPA) was examined for its possible prenatal developmental toxicity in a dose range finding study for a full prenatal developmental toxicity study (OECD 414). Groups of seven spermium-positive female Hsd. Han: Wistar rats were treated with the test item by oral administration daily at three dose levels of 100, 300 and 1000/460 mg/kg bw/day (the dose level of the high dose was reduced after mortality was observed) respectively from day 5 up to and including day 19 post coitum. A control group of seven spermium positive females was included and the animals were given the vehicle sunflower oil. The treatment volume was 4 mL/kg bw. During the study, mortality was checked and clinical observations were performed. Body weight and food consumption of the dams were also recorded. The day, when spermium was detected in the vaginal smear, was regarded as day 0 of gestation. Caesarean section and gross pathology were performed on gestational day 20. The number of implantations, early and late resorptions, live and dead fetuses in each uterine horn and the number of corpora lutea were recorded. Each fetus was weighed and examined for sex and gross external abnormalities. The placentas were weighed and examined externally.
The dose level of 1000 mg/kg bw/day of the test item caused clinical signs and death of two dams after treatment from gestation day 5 to 7. The test item caused death in a further dam after two treatments with 1000 mg/kg bw/day and one treatment with the reduced 460 mg/kg bw/day dose. The death of one dam in 300 mg/kg bw/day dose group was caused by misgavage and therefore is not test item related. During treatment from gestation day 5 to 19 with the dose level of 1000/460 mg/kg bw/day the test item caused clinical signs in one dam and in one female with total implantation loss even after reduction of the dose level. Similar clinical signs and necropsy findings were observed in one animal in the 300 mg/kg bw/day dose group. A test item related effect at 300 mg/kg bw/day was not considered due to the low incidence. There was no reduction in the food consumption and body weight parameters attributed to the test item considering the lack of dose response. The increase of early embryonic death in the 1000/460 mg/kg bw/day dose group was caused by one female with total post-implantation loss. The effect was considered treatment related, most likely secondary to the severe maternal toxicity demonstrated by the strong clinical symptoms. The mean number of implantations, viable fetuses per litters, percentage pre-implantation loss, late resorptions and fetal death were not affected by the test item. The treatment of the maternal animals did not result in reduced body weight of fetuses or increase of variations including body weight retardation. The test item caused no malformations in the fetuses.
Based on the maternal toxicity and effects secondary to maternal toxicity the dose range finding study determined the doses of 80, 240 and 460 mg/kg bw/d for the main study (OECD 414 (2018)). The NOAEL of the DRF study was determined to be 300 mg/kg bw/d based on maternal toxicity.
OECD 421
Furthermore, the effects of the structural analogue hexahydro-4-methylphthalic anhydride (4-MHHPA) on fertility, pregnancy and early lactation of the offspring have been investigated in a reproduction/developmental toxicity screening study conducted according to OECD 421. Groups of rats were dosed by oral gavage at levels of 50, 150 and 450 mg/kg/day. Males were treated for 2 weeks prior to pairing and during pairing of all females until the day before necropsy, for a total of 6 weeks. Females were treated for 2 weeks prior to pairing, during pairing and throughout the gestation and lactation periods and for 4 days post partum. No significant changes and no treatment-related effects were detected in males and females during the in vivo phase. Reproductive parameters such as fertility index, pre-coital interval and copulatory index did not show significant differences in treated groups compared to controls. Gestation length, litter data, sex ratios and implantation losses (pre and post) were unaffected by treatment. Findings at macroscopic and microscopic examinations, in both males and females, did not reveal differences between groups that could be related to treatment. On the basis of these findings, 450 mg/kg/day is considered to be the No Observed Adverse Effect Level (NOAEL).
Conclusion:
As an overall conclusion adverse effects caused by the test item in the dams and the effects regarding the dams and offspring, possibly due to the maternal toxicity, have been identified and the NOAEL for maternal and developmental toxicity including teratogenicity was determined to be 460 mg/kg bw/day for the structural analogue hexahydro-4-methylphthalic anhydride (4-MHHPA). According to the results of the read-across substance the NOAEL of 460 mg/kg bw/d is considered for the registration substance MHHPA for maternal and developmental toxicity.
Justification for classification or non-classification
Based on the results of the reproductive and developmental toxicity testing, MHHPA was not classified and labelled according to Regulation (EC) No 1272/2008 (CLP).
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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