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EC number: 228-250-8 | CAS number: 6197-30-4
- 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
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- 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
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-04-20 to 1993-07-23 (administration period)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subchronic oral toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1993-04-20 to 1993-07-23 (administration period)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents) adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents) 1988
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Male and female Wistar rats (Chbb : THOM (SPF)
- Source: Dr. Karl THOMAE , Biberach / Riss , FRG
- Age at study initiation: 42 days
- Weight at study initiation: 179 (168 - 188) g for the males, 137 (125 - 147) g for the females .
- Fasting period before study: no
- Housing: individually in type DK III stainless steel wire cages (floor area about 800 cm² )
- Diet (ad libitum): ground Kliba maintenance diet rat/mouse/hamster, 343 meal, KLINGENTALMÜHLE AG, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1993-04-13 To: 1993-07-23 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- no mating
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- continuously in the diet
- Remarks:
- Doses / Concentrations:
ca. 58, 175, 340, 1085 mg/kg bw/d
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
750, 2250, 4500, 15000 ppm in the diet
Basis:
nominal in diet - No. of animals per sex per dose:
- 10 males and 10 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale:
The doses were selected on two previous studies with the test substance.
In a gavage study, Uvinul N 539 was administered to 5 male and 5 female Wistar rats (Chbb :THOM SPF) in olive oil at a dose of 2,000 mg/kg body weight for 15 consecutive days. As a control, 5 male and 5 female rats were treated with vehicle only. Following findings were obtained:
Mortality and body weight was not affected. In the second week of the study, salivation was observed each time after administration of the test substance. The blood sampling at the end of the study revealed in treated males and females statistically significantly increased serum-gamma-glutamyltransferase (SGGT) values and cholesterole values; in treated males, creatinine, total protein, and globulins were increased, in females red blood cells, hemoglobin, and hematocrit were decreased. However, from the above mentioned changes in clinical chemistry and hematology only the changes in SGGT and cholesterole were assessed as being treatment-related. Urine was discolored (slightly red). In both sexes, liver weights were increased.
In a palatability study (BASF 10S0227/92057), Uvinul N 539 was administered to 3 Wistar rats (CHbb:THOM SPF) per sex and dose at doses of 0; 4500 and 15000 ppm in the diet for 2 weeks. No substance-related impairment of food consumption was observed. At the end of the study, the body weights of the animals of the 15000 ppm group were about 97/93% (males/females) of the control values. However, due to the slightness of the effect and the low number of animals, it cannot be ruled out that this was an incidental finding. - Positive control:
- no
- Parental animals: Observations and examinations:
- The first day of dosing was designated as day 0.
CAGE SIDE OBSERVATIONS and DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: The animals were examined for evident signs of toxicity twice a day (Mondays to Fridays) and once a day (Saturdays, Sundays and on public holidays). Once a week an additional comprehensive clinical examination was carried out.
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
The body weight was determined before the start of the administration period in order to randomize the animals. During the conduct of the study the body weight was determined on day 0 and thereafter once a week. The difference between the body weight on the respective day of weighing and the body weight on day 0 was calculated as the body weight change.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
Food consumption over a period of 7 days was determined weekly and calculated as mean food consumption in grams per animal and day. - Oestrous cyclicity (parental animals):
- no
- Sperm parameters (parental animals):
- no
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY: Yes
HISTOPATHOLOGY / ORGAN WEIGHTS: Yes - Statistics:
- The statistical evaluation and calculation of the data were carried out on the computer systems of the Department of Toxicology of BASF Aktiengesellschaft.
- Reproductive effects observed:
- not specified
The administration of Uvinul N 539 in the diet in different dosages did not result in any substance-related findings. All findings obtained were incidental and not attributable to the test substance administration.
During the entire study period no animal died prematurely.
BODY WEIGHT AND WEIGHT GAIN
Body weight was impaired in high dose males and females, resulting in reduced values of 10/ 8% (males / females) at the end of the study.
Body weight change was impaired in high dose males and females , resulting in reduced values of 16 / 15 % (males / females) at the end of the study.
Although the difference was not always statistically significantly, the effect was assessed as being substance-related.
FOOD CONSUMPTION and COMPOUND INTAKE
The overall food consumption was reduced in high dose males and females, the values being about 13 and 10% below the control values, respectively. The food consumption of all other treated animals was within the range of biological variation.
For calculated compound intake, see table below.
ORGAN WEIGHTS, PATHOLOGY, HISTOPATHOLOGY
The following substance-related findings concerning the reproductive system were recorded:
15000 ppm group:
- Increased number of hypertrophic cells in the pars distalis of the pituitary gland of males. The cells had
abundant pale eosinophilic cytoplasm and often contained large vacuoles. They tended to occur
in the middle of the pars distalis rather than in the lateral regions.
- Slight or moderate hypertrophy of the thyroid foilicular epithelium (all animals) and associated pale staining colloid in both sexes
4500 ppm group:
- Minimal or slight hypertrophy of the thyroid follicular epithelium and associated pale staining colloid in both sexes
2250/750 ppm group:
Few incidences of minimal changes in the thyroid gland (not considered as treatment-related)
No treatment related gross lesions were observed.
No changes in absolute and relative testes weights in males and adrenal weigths in males/females were observed.
No treatment related incidences of microscopic findings were observed in adrenal glands, epididymides, prostate, testes of males.
No treatment related incidences of microscopic findings were observed in adrenal glands, mammary gland, ovaries, uterus, vagina of females.
For further details see chapter 7.5.1.
Approximate food intake
Test group |
Concentration [ppm] |
Mean daily test substance intake [mg/kg bw/d] |
||
males |
females |
all animals |
||
1 |
750 |
53 |
63 |
58 |
2 |
2250 |
163 |
187 |
175 |
3 |
4500 |
315 |
365 |
340 |
4 |
15000 |
1027 |
1143 |
1085 |
For results other than those to reproductive organs, see section 7.5.1, Repeated dose toxicity: oral.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1988
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Octocrilene
- EC Number:
- 228-250-8
- EC Name:
- Octocrilene
- Cas Number:
- 6197-30-4
- Molecular formula:
- C24H27NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyano-3,3-diphenylacrylate
- Details on test material:
- - Name of test material (as cited in study report): Uvinul N 539
- Analytical purity: 98.3%
- Lot/batch No.: 505396-70182
- Stability under test conditions: confirmed
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Male and female Wistar rats (Chbb : THOM (SPF)
- Source: Dr. Karl THOMAE , Biberach / Riss , FRG
- Age at study initiation: 42 days
- Weight at study initiation: 179 (168 - 188) g for the males, 137 (125 - 147) g for the females .
- Fasting period before study: no
- Housing: individually in type DK III stainless steel wire cages (floor area about 800 cm² )
- Diet (ad libitum): ground Kliba maintenance diet rat/mouse/hamster, 343 meal, KLINGENTALMÜHLE AG, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1993-04-13 To: 1993-07-23
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- continuously in the diet
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 ppm
- Remarks:
- 53 (males); 63 (females); 58 (all animals) mg/kg bw/d
- Dose / conc.:
- 2 250 ppm
- Remarks:
- 163 (males); 187 (females); 175 (all animals) mg/kg bw/d
- Dose / conc.:
- 4 500 ppm
- Remarks:
- 315 (males); 365 (females); 340 (all animals) mg/kg bw/d
- Dose / conc.:
- 15 000 ppm
- Remarks:
- 1027 (males); 1143 (females); 1085 (all animals) mg/kg bw/d
- No. of animals per sex per dose:
- 10 males and 10 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale:
The doses were selected on two previous studies with the test substance.
In a gavage study, Uvinul N 539 was administered to 5 male and 5 female Wistar rats (Chbb :THOM SPF) in olive oil at a dose of 2,000 mg/kg body weight for 15 consecutive days. As a control, 5 male and 5 female rats were treated with vehicle only. Following findings were obtained:
Mortality and body weight was not affected. In the second week of the study, salivation was observed each time after administration of the test substance. The blood sampling at the end of the study revealed in treated males and females statistically significantly increased serum-gamma-glutamyltransferase (SGGT) values and cholesterole values; in treated males, creatinine, total protein, and globulins were increased, in females red blood cells, hemoglobin, and hematocrit were decreased. However, from the above mentioned changes in clinical chemistry and hematology only the changes in SGGT and cholesterole were assessed as being treatment-related. Urine was discolored (slightly red). In both sexes, liver weights were increased.
In a palatability study (BASF 10S0227/92057), Uvinul N 539 was administered to 3 Wistar rats (CHbb:THOM SPF) per sex and dose at doses of 0; 4500 and 15000 ppm in the diet for 2 weeks. No substance-related impairment of food consumption was observed. At the end of the study, the body weights of the animals of the 15000 ppm group were about 97/93% (males/females) of the control values. However, due to the slightness of the effect and the low number of animals, it cannot be ruled out that this was an incidental finding. - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- The first day of dosing was designated as day 0.
CAGE SIDE OBSERVATIONS and DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: The animals were examined for evident signs of toxicity twice a day (Mondays to Fridays) and once a day (Saturdays, Sundays and on public holidays). Once a week an additional comprehensive clinical examination was carried out.
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
The body weight was determined before the start of the administration period in order to randomize the animals. During the conduct of the study the body weight was determined on day 0 and thereafter once a week. The difference between the body weight on the respective day of weighing and the body weight on day 0 was calculated as the body weight change.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
Food consumption over a period of 7 days was determined weekly and calculated as mean food consumption in grams per animal and day.
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: 1 days prior to the first dose and 84 days after beginning of treatment
- Dose groups that were examined: control and 15000 ppm group
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 85 days after beginning of treatment
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: all animals
- Parameters examined: leukocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, differential blood count, reticulocytes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 85 days after beginning of treatment
- Animals fasted: No
- How many animals: all animals
- Parameters examined: prothrombin time (Hepato Quick's test), alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum gamma-glutamyltransferase, sodium, potassium, chloride, inorganic phosphate, calcium, urea, creatinine, glucose, total bilirubin, total protein, albumin, globulins, triglycerides, cholesterol, magnesium
URINALYSIS: Yes
- Time schedule for collection of urine: 79 days after beginning of treatment
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No
- Parameters examined: volume, color, turbidity, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood, specific gravity, sediment
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- The statistical evaluation and calculation of the data were carried out on the computer systems of the Department of Toxicology of BASF Aktiengesellschaft.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
The administration of Uvinul N 539 in the diet in different dosages did not result in any substance-related findings. All findings obtained were incidental and not attributable to the test substance administration.
During the entire study period no animal died prematurely.
BODY WEIGHT AND WEIGHT GAIN
Body weight was impaired in high dose males and females, resulting in reduced values of 10/ 8% (males / females) at the end of the study.
Body weight change was impaired in high dose males and females , resulting in reduced values of 16 / 15 % (males / females) at the end of the study.
Although the difference was not always statistically significantly, the effect was assessed as being substance-related.
FOOD CONSUMPTION and COMPOUND INTAKE
The overall food consumption was reduced in high dose males and females, the values being about 13 and 10% below the control values, respectively. The food consumption of all other treated animals was within the range of biological variation.
For calculated compound intake, see table below.
OPHTHALMOSCOPIC EXAMINATION
The ophthalmological examinations revealed no substance-related findings.
HAEMATOLOGY, CLINICAL CHEMISTRY, URINALYSIS
The following substance-related findings were recorded:
15000 ppm group
- decrease in hemoglobin mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), alanine aminotransferase and aspartate aminotransferase in the females
- increase in platelets in both sexes and shortened prothrombin time in the females
- increase in gamma-glutamyltransferase activity in both sexes
- increase in alkaline phosphatase, total protein, globulins and total cholesterol in the females
- dark yellow discoloration of the urine specimens in both sexes
- decrease in total bilirubin in both sexes
4500 ppm group
- increase in platelets, total protein and globulins in the females
- decrease in alanine aminotransferase and aspartate aminotransferase in the females
- decrease in total bilirubin in both sexes
ORGAN WEIGHTS, PATHOLOGY, HISTOPATHOLOGY
The following substance-related findings were recorded:
15000 ppm group:
- increased absolute and relative liver weights in male and female rats
- prominent acinar pattern of the liver in 7 out of 10 male rats
- hypertrophy of periacinar hepatocytes in both sexes
- hypertrophy of centriacinar hepatocytes in both sexes
- slight or moderate hypertrophy of the thyroid, follicular epithelium and associated pale staining colloid in both sexes
- increased number of hypertrophic cells in the pituitary gland of males
4500 ppm group:
- increased absolute and relative liver weights in female rats
- hypertrophy of periacinar hepatocytes in both sexes
- hypertrophy of centriacinar hepatocytes in males
- minimal or slight hypertrophy of the thyroid follicular epithelium and associated pale staining colloid in both sexes
2250/750 ppm group:
Few incidences of minimal changes in the thyroid gland (not considered as treatment-related)
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 250 ppm
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: approx. 175 mg/kg bw/d
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Approximate mean food intake
Test group |
Concentration [ppm] |
Mean daily test substance intake [mg/kg bw/d] |
||
males |
females |
all animals |
||
1 |
750 |
53 |
63 |
58 |
2 |
2250 |
163 |
187 |
175 |
3 |
4500 |
315 |
365 |
340 |
4 |
15000 |
1027 |
1143 |
1085 |
Applicant's summary and conclusion
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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