Registration Dossier
Registration Dossier
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EC number: 213-911-5 | CAS number: 1066-33-7
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data taken from OECD SIDS; guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report For SIAM 15
- Author:
- OECD
- Year:
- 2 003
- Bibliographic source:
- SIDS Dossier Sodium Bicarbonate, Final July 2003
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- - Name of test material (as cited in study report): sodium bicarbonate
- Analytical purity: > 99.5%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidsons Mill Farm, 5. Brunswick, NJ
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g / 0.5 ml distilled water - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm2 of skin clipped free of hair, either dorsal or lateral on the rabbit
- Type of wrap if used: the test site was immediately after application covered with a 2-7/8x4-1/2 in adhesive-backed gauze patch which was loosely held in contact with the skin by use of a semi-occlusive elastic cloth overwrap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped clean of any residual test substance
- Time after start of exposure: 4 h
SCORING SYSTEM:
According to the Draize scoring system.
The average erythema and oedema scores for the 1, 24, 48 and 72 hrs scoring intervals were added. The resultant value was divided by the number of evaluation intervals (4).
- Examination time points: Skin sites were evaluated at approximately 30 - 60 minutes, 24, 48 and 72 hrs after patch removal and scored.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.07
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 110
- Reversibility:
- fully reversible
Any other information on results incl. tables
Average scores for erythema and edema:
| Erythema | Edema | |
| 1 h | 0.7 | 0.2 |
| 24 h | 0.2 | 0 |
| 48 h | 0 | 0 |
| 72 h | 0 | 0 |
| mean 24- 72 h | 0.07 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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