Registration Dossier
Registration Dossier
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EC number: 908-552-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study with minor deviations, fully adequate for assessment. In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Test substance was not moistened with water ; patch was occlusive instead of semi-occlusive. Minor deviations included small differences in housing conditions and no other toxic effects have been observed
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium carbonate
- EC Number:
- 207-838-8
- EC Name:
- Sodium carbonate
- Cas Number:
- 497-19-8
- Molecular formula:
- CH2O3.2Na
- IUPAC Name:
- disodium carbonate
- Details on test material:
- SOURCE: Chem. Fabrik Kalk GmbH, Köln, Germany
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: Name (in german) of test substance:
"Leichte calc. Soda" (Eng.: Light calcined soda)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Sex: Not reported.
- Source: Harald Schriever, Rabbit farm, Germany.
- Age: Not reported.
- Weight at study initiation: 2.4 - 2.6 kg.
- Number of animals: 6
- Controls: Included but not described
Test system
- Type of coverage:
- occlusive
- Vehicle:
- other: other
- Controls:
- yes
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+48+72 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+48+72 hour
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: not irritating
- Executive summary:
Classification: not irritating
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