Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no observation period of 14 days, no subdivision of the scores after 72 hourss
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12 animals
6 animals intact skin
6 animals abraded skin
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM: By the method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 3
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 4
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 5
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 6
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 4
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 5
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 6
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
After 24 hours, ischemia and slight to severe edema; after 72 hours, distinct or severe incrustation.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The skin irritation potential of the test substance was determined in a study equivalent to OECD guideline 404. The test item showed corrosive effects.
Executive summary:

The skin irritation potential of the test item was determined in a study equivalent to OECD guideline 404. The test substance was applied undiluted in an amount of 0.5 mL. Six rabbits are treated on the intact skin, the other six on the abraded skin. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. After an exposure period of 24 hours the patches were removed. The resulting skin reaction were read immediately after 24 hours and after 72 hours. The following scores are indicated as overall mean irritation scores after 72 hours. No subdivision was done for the scores after 72 hours:

Intact skin

Animal 1: 3

Animal 2: 3

Animal 3: 3

Animal 4: 3

Animal 5: 3

Animal 6: 4

Abraded skin

Animal 1: 3

Animal 2: 3

Animal 3: 4

Animal 4: 4

Animal 5: 4

Animal 6: 3

The test item showed skin corrosive effects. The effects were not reversibel after 72 h. After 24 hours, ischemia and slight to severe edema; after 72 hours, distinct or severe incrustation were observed.