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Toxicological information

Skin irritation / corrosion

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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:
2003
Bibliographic source:
SIDS Dossier Sodium Bicarbonate, Final July 2003
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sodium bicarbonate
- Analytical purity: > 99.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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