Registration Dossier
Registration Dossier
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EC number: 208-580-9 | CAS number: 533-96-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, fully adequate for assessment. In the OECD SIDS on sodium bicarbonate (2002) a similar reliability was assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium bicarbonate
- IUPAC Name:
- sodium bicarbonate
- Details on test material:
- purity > 99.5%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Strain: New Zealand Albino.
- Sex: 3 males and 3 females.
- Source: Davidson's Mill Farm, S. Brunswick, NJ.
- Age: Not reported.
- Weight at study initiation: Not reported.
- Number of animals: 6.
- Controls: Not reported.
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4h
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0.3
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0.07
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 24 h
Any other information on results incl. tables
AVERAGE SCORE
- Erythema: 1 hour: 0.7. 24 hrs: 0.2. 48 hrs: 0. 72 hrs: 0.
- Edema: 1 hour: 0.2. 24 hrs: 0. 48 hrs: 0. 72 hrs: 0.
REVERSIBILITY: The effects were fully reversible.
OTHER EFFECTS: Not reported. The Primary Dermal Irritation Index (PDII) was 0.3. The substance is slightly irritating.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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