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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:
1977
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Draize, John H.: Dermal toxicity, "Appraisal of the safety of chemicals in foods, Drugs and Cosmetics", Association of food and drug officials of the US, 1959, pp 46-48
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
- Name of test material (as cited in study report): Diacid 1550, K-salt (trade name: "H-240 100%")
- Physical state: amber solid
- Storage condition of test material: At room temperature in original, sealed container

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals and environmental conditions:
The animals were kept under observation at least 7 days prior to experimental use, during which period they were examined with respect to their general health and suitability as test animals. The animals were housed in suspended, wire bottomed steel cages and mantained on a standard laboratory diet. Food and water were offered ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: for each animal two sites were tested: one site abraded, one site intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL / site
Duration of treatment / exposure:
24 h
Observation period:
After treatment (24 h) the animals were observed one hour after removal of the test material and again after 72 hours
Number of animals:
6
Details on study design:
The test material was applied to the test sites on each rabbit according to the treatment procedure. Each test site was immediately occluded with a 2-inch square gauze patch which was secured with masking tape. The trunk of each animal was then wrapped with impervious plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the 24 hour exposure period.
At the end of the 24 hours the plastic wrappings and patches were removed. In addition, all residual test material was removed by rinsing the test sites with lukewarm tap water (or a suitable solvent) and gentle rubbing. One hour after removal of the test material, each abraded and intact test site was examined and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours the sites were again examinated and scored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
3.3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2.7
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not determinable because of methodological limitations
Remarks:
only 24h and 72h values were reported
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not determinable because of methodological limitations
Remarks:
only 24h and 72h values were reported

Any other information on results incl. tables

Sites with second degree chemical burns (noted as moderate to diffuse) were given maximum irritation scores of 4 for both erythema and edema to obtain a primary irritation score.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The primary irritation score found was 6.2 out of 8 for intact skin and the substance was scored as severly irritating to intact skin.
Executive summary:

The primary irritation score found was 6.2 out of 8 for intact skin and the substance was scored as severly irritating to intact skin. A slight reduction in scores between the 24 hour and the 72 hour reading was seen, but in lack of an observation period a final assessment about reversibility cannot be made.