Registration Dossier

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:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity > 99.5%

Test animals

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