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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:
1982
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:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL of undiluted test substance (50% pure)
Duration of treatment / exposure:
4 or 1 h
Observation period:
4 or 1 hour, 48 h and 10 days
Number of animals:
Six males and females
Details on study design:
Six healthy adult New Zealand White albino rabbits (M/F) were used for the test. 24 hours prior to applying the test substance, the hair was removed from the back of the animals with electric clippers in such a way as to avoid abrasions.

An amount of 0.5 mL of the undiluted test substance was brought on the intact skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.

Each rabbit was treated on the intact skin. The abrasions were minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.

After an exposure period of 4 or 1 hour the patches and the test substance applied were removed and the resulting skin reactions were evaluated by the method of Draize scoring. A second reading was made 48 hours later.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
ca. 0.85
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Study II, following exposure period of 1 hour
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 h
Score:
4
Max. score:
8
Reversibility:
not reversible
Remarks:
within 10 days
Remarks on result:
other: Study I, following exposure period of 4 hours
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 3.84
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: well-defined to moderate erythema
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 1.08
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: very slight to moderate erythema
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 10 dys
Remarks on result:
other: very slight to slight edema
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 1.58
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: very slight or slight edema
Irritation parameter:
overall irritation score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 5.4
Max. score:
8
Reversibility:
not reversible
Remarks:
within 10 days
Remarks on result:
other: Corrosive to skin
Irritation parameter:
overall irritation score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 1.25
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: corrosive to skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Observations in 4 hours test:
- After 4 hours: Very slight to well-defined erythema, very slight ischemia and very slight edema
- After 48 hours: Well-defined to moderate erythema, very slight to slight ischemia and very slight or slight edema
- After 10 days: Slight to distinct incrustation and decreased hair growth

Observations in 1 h test:
After 1 h: Very slight erythema
After 48 h: Very slight to moderate erythema and very slight or slight edema
After 10 d: No skin effects were observed

Any other information on results incl. tables

For result tables, kindly refer to the attached background material section of the IUCLID.

Applicant's summary and conclusion

Interpretation of results:
other: Category 1C based on CLP criteria
Conclusions:
Under the study conditions, the undiluted test substance (i.e., 50% active ingredient) was considered to be corrosive to the rabbit skin after 4 h of occlusive exposure.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance, C16 -18 and C18 -unsatd. TMAC (50% active) in rabbits, according to a method similar to OECD Guideline 204. Six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% active ingredient) in an occlusive patch fixed with adhesive tape and wrapped with an impervious material, for 4 h. Observations were made at 4 h, 48 h and 10 days post-exposure. If the test substance appeared to be corrosive after 4 h, another study was conducted with a 1 h exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 h, very slight to well-defined erythema, very slight ischemia and very slight oedema were observed, with an average irritation score of 4/8. At 48 h, there was well-defined to moderate erythema, very slight to slight ischemia and very slight or slight oedema and the average irritation score was 5.4/8. After 10 days, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 h, very slight erythema was observed with an average irritation score of 0.85/8. After 48 h, there was very slight to moderate erythema and very slight or slight oedema and the average irritation score was 1.25/8. No skin effects were observed after 10 days. Under the study conditions, the undiluted test substance (50% active ingredient) was corrosive after 4 h of occlusive exposure.