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Diss Factsheets
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EC number: 620-582-5 | CAS number: 301341-58-2
- 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)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Sodium cocoyl glycinate (SCG) [INCI]
- IUPAC Name:
- Sodium cocoyl glycinate (SCG) [INCI]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories BV
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 199 - 233 g (males), 133 - 154 g (females)
- Fasting period before study: yes (overnight)
- Housing: in groups of 5 in Makrolon type-4 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark / light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): n.a.
- Mixing appropriate amounts with (Type of food): n.a.
- Storage temperature of food: n.a.
VEHICLE
- Justification for use and choice of vehicle (if other than water): purified water
- Concentration in vehicle: 0 - 100 mg/mL
- Amount of vehicle (if gavage): 10 mL (dose volume) - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: until evidence of copulation (up to 14 days pairing period)
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 14 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged: individually
- Any other deviations from standard protocol: no - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males: minimum 4 weeks
Females: approximately 7 weeks - Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 62.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 11 per sex per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on dose-range-finding study
- Rationale for animal assignment: random
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily from start of treatment to day of necropsy
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): n.a.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): n.a. - Sperm parameters (parental animals):
- Parameters examined in [all/P/F1/F2] male parental generations:
No abnormal microscopic findings during sperm staging regarding completeness of stages and maturation of cell populations. - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was determined for pups born or found dead - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals after treatment for 28 days.
- Maternal animals: All surviving animals on day 21 post coitum (if birth did not occur at that day, the dam was sacrificed on day 25 post coitum).
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS - Postmortem examinations (offspring):
- SACRIFICE
The F1 offspring were sacrificed at 4 days of age.
GROSS NECROPSY
No test item related findings in any pubs at any dose level observed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
No mortality occurred. No significant test item-related clinical signs were noted at any dose level.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS):
A reduction of food consumption at the dose level of 1000 mg/kg body weight per day was noted in males and females. A related but not statistically significant reduction in body weights was noted only in male animals but not in females.
REPRODUCTIVE FUNCTION:
No effects observed.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
No abnormal lesions noted during microscopic staging regarding completeness of stages and maturation of cell populations.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS):
No effects on mating performance or fertility was observed at any dose level.
ORGAN WEIGHTS (PARENTAL ANIMALS):
No changes in organ weights considered to be test item-related were noted at any dose level.
GROSS PATHOLOGY (PARENTAL ANIMALS):
Individual findings in male animals were within the range of the normal background of animals from this strain. No test item-related findings were noted in females at any dose level.
HISTOPATHOLOGY (PARENTAL ANIMALS):
No histopathological findings attributable to the treatment with the test item could be observed. No test item related findings related to ovaries, testes and epididymides could be detected.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Mean value of living pubs per dam at first litter check was in the range of historical controls.
CLINICAL SIGNS (OFFSPRING):
No test item-related observations were noted in pubs during the first litter check or during lactation at any dose level.
BODY WEIGHT (OFFSPRING):
No effects on pub body weights were noted at any dose level.
GROSS PATHOLOGY (OFFSPRING):
No test item-related findings were found in pubs at any dose level.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results, the NOAEL of Hostapon SG for general toxicity in male and female parental animals is considered to be 1000 mg/kg body weight per day. A test item related influence on the offspring with regard to an increased post-implantation and postnatal loss observed in this study cannot be excluded. However, these effects are most probably attributable to the high sodium chloride content of the test item and thus are not considered to reflect substance specific toxicity.
- Executive summary:
Hostapon SG Dried was administered in highly purified water as vehicle at dosages of 62.5, 250, and 1000 mg/kg body weight/day, and controls received the vehicle only. Hostapon SG Dried was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Test item-related effects were observed at the dose level of 1000 mg/kg bw/day, no of them was considered to be adverse.
Treatment with the test item at the high-dose level caused also a reduction in food consumption of males and females. In males, reduction in food consumption was accompanied by a reduction in body weights observed during the entire study period and a reduction in body weight gain which was significant during the pre-pairing but recovered during the pairing period. In females no effects on body weights or body weight gain were noted. The effects on food consumption, body weights and body weight gain at the high dose level were considered not to be adverse.
During necropsy and following histopathological examination no significant test item-related findings were noted in males and females at any dose level. There were no microscopic abnormal lesions encountered during sperm staging regarding completeness of stages and maturation of cell populations. There were no findings noted that could be attributed to treatment with the test item, Hostapon SG. The findings observed were within the range of normal background lesions which may be recorded in animals of this strain and age.
No effects on mating performance, fertility, corpora lutea count or duration of gestation were observed at any dose level. At the dose level of 1000 mg/kg bw/day, higher incidences of post-implantation loss and higher postnatal loss as well as lower litter size at first litter check and on day 4 post partum were noted.
No test item-related findings were noted at first litter check and during lactation in pups at any dose level.
Based on the results, the NOAEL of Hostapon SG for general toxicity in male and female parental animals is considered to be 1000 mg/kg body weight per day. A test item related influence on the offspring with regard to an increased post-implantation and postnatal loss observed in this study cannot be excluded. However, these effects are most probably attributable to the high sodium chloride content of the test item and thus are not considered to reflect substance specific toxicity.
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.
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