Registration Dossier
Registration Dossier
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EC number: 205-633-8 | CAS number: 144-55-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- Molecular formula:
- CH2O3.Na
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- SOURCE: Not reported.
PURITY: > 99.5%
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: Not reported.
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
- Amount / concentration applied:
- Concentration: 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.07
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hr
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
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