Registration Dossier
Registration Dossier
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EC number: 500-151-7 | CAS number: 61791-12-6 1 - 6.5 moles ethoxylated
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of PEG-30, -33, -35, -36, and - 40 castor oil and PEG- 30 And -40 hydrogenated castor oil
- Author:
- Susan N. J. Pang
- Year:
- 1 997
- Bibliographic source:
- Cosmetic Ingredient Review; International Journal of Toxicology, 16:269-306,1997.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- test material was tested for teratogenic effects in a feeding study with Sprague –Dawley rats for days 0 to 20 of gestation study period.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Castor oil, hydrogenated, ethoxylated
- IUPAC Name:
- Castor oil, hydrogenated, ethoxylated
- Reference substance name:
- Castor oil, hydrogenated, ethoxylated
- EC Number:
- 500-147-5
- EC Name:
- Castor oil, hydrogenated, ethoxylated
- IUPAC Name:
- 500-147-5
- Reference substance name:
- 61788-85-0
- Cas Number:
- 61788-85-0
- IUPAC Name:
- 61788-85-0
- Details on test material:
- - Name of test material (as cited in study report): PEG-40 Hydrogenated Castor Oil
- Substance type:Organic
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- No details available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: diet
- Details on exposure:
- 1) Two groups of pregnant rats, 30 in one group and 27 in the other were fed diets containing test substance.
2) Two control groups of 26 and 29 rats were fed untreated feed. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No details available
- Duration of treatment / exposure:
- 0 to 20 days of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,5000,10000 mg/kg
Basis:
- No. of animals per sex per dose:
- 1st group: 30 pregnant rats.
2nd group: 27 pregnant rats.
1st control group: 26 pregnant rats.
2nd control group : 29 pregnant rats. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No details available
Examinations
- Maternal examinations:
- All pregnant rats were observed for sign of toxicity during gestation and killed on day 20 for evaluation of the uteri.
- Ovaries and uterine content:
- Yes examined
- Fetal examinations:
- Yes examined for toxicity
- Statistics:
- No details available
- Indices:
- No details available
- Historical control data:
- No details available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight but not statistically significant increase occurred in the number of resorptions in the group treated with 100000 mg/kg
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
-No evidence of maternal toxicity was observed.
-Slight but not statistically significant increase occurred in the number of resorptions in the group treated with 10000 mg/kg
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: -Slight but not statistically significant increase occurred in the number of resorptions in the group treated with 100000 mg/kg
- Remarks on result:
- other: No toxic effects observed at 5000mg/kg dose group
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
-The malformation and anomalies found in the fetuses of the experimental groups were similar to those found among the fetuses from the control groups which are not significant.
-No evidence of fetal toxicity was observed.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 mg/kg diet
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: No developmental toxic effects pobserved
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The no observed adversed effect level (NOAEL) for teratogenicity study is considered to be 10000 mg/kg. When female rats were treated with test material orally.
- Executive summary:
A teratogenic study was conducted to evaluate the fetal toxicity effects in the rat fetous by test compound to rats orally. In first group 30 pregnant rats and in second group 27 pregnant rats were fed diets containing test substance and in two control groups of 26 and 29 rats were fed untreated feed on daily basis for 20 days gestation period. During study period test animals were given 0(vehicle), 5000, 10000 mg/kg . Slight but not statistically significant increase occurred in the number of resorptions in the group treated with 10000 mg/kg.Test material does not show the malformation and anomalies found in the fetuses of the experimental groups were similar to those found among the fetuses from the control groups which are not significant. Overall conclusion of the study is there was no evidence of the test substance shows any fetal toxicity. Hence the no observed adversed effect level (NOAEL) for teratogenicity study is considered to be 10000 mg/kg. When female rats were treated with test material orally.
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