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Toxicological information

Skin irritation / corrosion

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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:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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.

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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