Registration Dossier
Registration Dossier
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EC number: 908-531-8 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- For this endpoint, an analysis based on the components is performed. Based on SIDS report on Sodium carbonate, the toxicity on developmental toxicity is not of concerned whatever the route of administration. Based on the SIDS report and EU-RAR about sodium hydroxide, the toxicity on developmental toxicity is not of concerned whatever the route of administration. Based on a teratogenicity study on Na2S registration dossier, the NOAEC inhalatory is as minimum the NOAEC which could be considered for the developmental toxicity.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fertility and development neurotoxicity effects if inhaled hydrogen sulfide in Sprague-Dawley rats
- Author:
- Dorman et al
- Year:
- 2 000
- Bibliographic source:
- Neurotox, Teratology
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 421
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrogen sulphide
- EC Number:
- 231-977-3
- EC Name:
- Hydrogen sulphide
- Cas Number:
- 7783-06-4
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- 80 ppm
- Basis for effect level:
- other: no relevant alterations in haematological indices, serum chemistries or gross pathology
Maternal abnormalities
- Abnormalities:
- no effects observed
- Localisation:
- not specified
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 80 ppm
- Sex:
- male/female
- Basis for effect level:
- other: no teratogenic effects or changes in the behavioural were observed
Fetal abnormalities
- Abnormalities:
- no effects observed
- Localisation:
- other: different organ tested
Overall developmental toxicity
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 80 ppm
- Dose response relationship:
- not specified
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- The NOAEC used and estimated for the multi-constituent is equal to 80 ppm (equivalent to approximately 410 mg/m3)
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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