Registration Dossier
Registration Dossier
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EC number: 931-319-1 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: According to the OECD SIDS document for sodium hydroxide (March 2002), a Klimisch 3 reliability score was assigned since an unsuitable test system is used.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of Some Nonspecific Factors Accompanying Intraamniotic Injection in Mouse Foetus Folia Morphol.
- Author:
- Dostal M
- Year:
- 1 973
- Bibliographic source:
- Folia Morphol, 21: 97-101
Materials and methods
- Principles of method if other than guideline:
- On the 13th day of gestation, 2 µl 0.001 M NaOH solution was injected intraamniotically to groups of foetuses from 7 females. The results were read on the 16th day of gestation. Foetal mortality and the incidence of cleft palate in surviving embryos were studied.
- GLP compliance:
- no
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- no data
Test animals
- Species:
- mouse
- Strain:
- other: random-bred H-Velaz
Administration / exposure
- Route of administration:
- other: intraamniotically
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Frequency of treatment:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2 µl of 0.001M NaOH
Basis:
- No. of animals per sex per dose:
- groups of foetuses from 7 females
- Control animals:
- yes
- Details on study design:
- Sex: female
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The mortality of foetuses was 46 % but no mortality was found in the surviving foetuses. No cleft palates were observed.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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.
