Registration Dossier
Registration Dossier
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EC number: 500-038-2 | CAS number: 25322-68-3 1 - 4.5 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenic effects of Polyethylene Glycol 200 in the Mouse but not In the Rat.
- Author:
- VANNIER, B., R. BREMAUD, M. BENICOURT and P. JULIEN
- Year:
- 1 989
- Bibliographic source:
- TERATOLOGY; EUROPEAN TERATOLOGY SOCIETY; 40:267-304 (1989)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- In developmental toxicity test the teratogenic effects of the test chemical to female rat by oral route were assessed in a one generation in an overall estimation of 6-14 or 11-16 days of gestation.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- EC Number:
- 500-038-2
- EC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Cas Number:
- 25322-68-3
- Molecular formula:
- (C2-H4-O)mult-H2-O
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report):Polyethylene Glycol 200
- Molecular weight (if other than submission substance):200
Constituent 1
- Specific details on test material used for the study:
- - Molecular weight (if other than submission substance): 200 daltons
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- No Data Available
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Rats were orally dosed on gestation days 6-14 or 11-16 with 1.5 to 5 ml/animal/day.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Details on mating procedure:
- Time Mated females were used in the study.
- Duration of treatment / exposure:
- 6-14 or 11-16 days of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.5 - 5 mg/animal/day
Basis:
- No. of animals per sex per dose:
- No Data Available
- Control animals:
- not specified
- Details on study design:
- No Data Available
Examinations
- Maternal examinations:
- Maternal animals were observed for any mortality.
- Ovaries and uterine content:
- No Data Available
- Fetal examinations:
- Body weight and Fetal loss were examined.
- Statistics:
- No Data Available
- Indices:
- No Data Available
- Historical control data:
- No Data Available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Maternal death were observed at administered doses.
- 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
- Details on results:
- No Data Available
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal deaths occured at mentioned dosages.
Effect levels (maternal animals)
- Remarks on result:
- not measured/tested
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -Foetal loss and foetal bodyweight remained within normal limits.
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -Foetal loss and foetal bodyweight remained within normal limits.
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
-Foetal loss and foetal bodyweight remained within normal limits.
- No malformations were observed.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 - 5 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The negative teratogenic effects on foetal body weight,foetal loss and malformation by the test chemical was observed at dose concentration 1.5 - 5 ml/animal/day (equivalent to 1500 -5000 mg/kg bw/d) in 6-14 or 11-16 days of gestation period. Thus, LOAEL (No observed adversed effect level) for teratogenicity study is considered to be 1.5 - 5 ml/animal/day (equivalent to 1500 -5000 ng/kg bw/d).
- Executive summary:
A teratogenic study was conducted to evaluate the foetal body weight,foetal loss and any kind of malformation by the test chemical to female rats orally dosed on gestational days 6-14 or 11-16 with 1.5 -5 ml/animal/day (equivalent to 1500 -5000 ng/kg bw/d). The test chemical was shown to have negative teratogenic effects as Foetal loss and foetal body weight remained within normal limits and no malformations were observed in rats after administration of dosage 1.5 -5 ml/animal/day (equivalent to 1500 -5000 mg/kg bw/d) of the test chemical. Since LOAEL (Low observed adversed effect level) is 1.5 -5 ml/animal/day (equivalent to 1500 -5000 mg/kg bw), it is regarded that there is no teratogenic effectsin the fetuses at concentrations 1.5 -5ml/animal/day (equivalent to 1500 -5000 mg/kg bw/d) when administered orally.
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