Registration Dossier
Registration Dossier
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EC number: 248-230-2 | CAS number: 27115-36-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 13 day dosing period
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data taken from review document with limited method details, although claiming to be OECD complient
Chromium formate will dossiciate in solution and the effects of sodium formate is an indicator of effects of the formate ion.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics
- Author:
- Johnson, W et al
- Year:
- 2 016
- Bibliographic source:
- International Journal of Toxicology 2016, Vol. 35(Supplement 2) 41S-54S
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Full details not in the review document
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium formate
- EC Number:
- 205-488-0
- EC Name:
- Sodium formate
- Cas Number:
- 141-53-7
- Molecular formula:
- CH2O2.Na
- IUPAC Name:
- Sodium formate
Constituent 1
- Specific details on test material used for the study:
- Not specified
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Not specified
- Duration of treatment / exposure:
- Gestational days 6 to 19. The animals were 70 to 84 days old at gestational day 0.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 59 mg/kg bw/day (nominal)
- Dose / conc.:
- 236 mg/kg bw/day (nominal)
- Dose / conc.:
- 945 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 23 - 25 female rats
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Weight and clinical examinations with gross necropsy examiniations
- Ovaries and uterine content:
- Uterus weights
- Fetal examinations:
- Yes, in accordance with guidelines
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
- Other effects:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- There were no substance-related and/or biologically-significant differences among the test groups in the conception rate, the mean number of corpora lutea and implantation sites
Effect levels (maternal animals)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One out of 212 high-dose foetus showed external malformation, but not considered treatment related.
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Two soft tissue variations (uni- or bilateral dilatation of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any
dose-dependent relationship
Effect levels (fetuses)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Formic acid and salts are naturally occuring metabolites found in cells.
No adverse effects were reported.
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