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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

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
Type:
Constituent
Type:
Constituent
Type:
Constituent

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)
Amount / concentration applied:
0.5 mL of undiluted test substance (50% pure)
Duration of treatment / exposure:
4 or 1 hour
Observation period:
4 or 1 hour, 48 hours 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: 4 h
Score:
4
Max. score:
8
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: Study I, following exposure period of 4 hours
Remarks:
(corrosive study)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
5.4
Max. score:
8
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: Study I, following exposure period of 4 hours
Remarks:
(corrosive study)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
0.85
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Study II, following exposure period of 1 hour
Remarks:
(corrosive study)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1.25
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Study II, following exposure period of 1 hour
Remarks:
(corrosive study)
Irritation parameter:
erythema score
Basis:
animal: 1 and 2
Time point:
other: 4 h
Score:
ca. 4
Max. score:
8
Reversibility:
not fully reversible within: not specified for individual animals
Remarks on result:
positive indication of irritation
Remarks:
(corrosive study)
Irritation parameter:
edema score
Basis:
animal: 1, 2, 3, 5 and 6
Time point:
other: 4 h
Score:
ca. 1
Max. score:
8
Reversibility:
other: not specified for individual animals
Remarks on result:
positive indication of irritation
Remarks:
(corrosive study)
Irritation parameter:
erythema score
Basis:
animal: 3, 4 and 5
Time point:
other: 4 h
Score:
ca. 2.5
Max. score:
8
Reversibility:
other: not specified for individual animals
Remarks on result:
positive indication of irritation
Remarks:
(corrosive study)
Irritation parameter:
edema score
Basis:
animal: 4
Time point:
other: 4 h
Score:
ca. 0.5
Max. score:
8
Reversibility:
other: not specified for individual animals
Remarks on result:
probability of mild irritation
Remarks:
(corrosive study)
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 4 and 6
Time point:
other: 1 h
Score:
ca. 0.5
Max. score:
8
Reversibility:
other: not specified for individual animals
Remarks on result:
probability of mild irritation
Remarks:
(corrosive study)
Irritation parameter:
edema score
Basis:
animal: 1, 2, 3, 4, 5 and 6
Time point:
other: 1 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: not specified for individual animals
Remarks on result:
no indication of irritation
Remarks:
(corrosive study)
Irritation parameter:
erythema score
Basis:
animal: 2 and 4
Time point:
other: 1 h
Score:
ca. 0.5
Max. score:
8
Reversibility:
other: not specified for individual animals
Remarks on result:
probability of mild irritation
Remarks:
(corrosive study)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Refer to the attached document for details on results
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Refer to the attached document for details on results
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Refer to the attached document for details on results
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Refer to the attached document for details on results
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Refer to the attached document for details on results
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Refer to the attached document for details on results
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

Refer to the attachment for details on results

Applicant's summary and conclusion

Interpretation of results:
other: Category 1C based on CLP criteria
Conclusions:
Based on the results of the read across study, the test substance, Oleyl TMAC is also considered to corrosive to rabbit skin after 4 h of occlusive exposure.
Executive summary:

A study was conducted to determine dermal irritation potential of the read across substance, C16-18 and C18-unsatd. TMAC (active: 50%), in rabbits, according to a method similar to OECD Guideline 404. In the study, six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% a.i.) 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 d 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 d, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 hour, 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 d. Under the test conditions, the undiluted test substance (50% a.i.) was concluded to be non-corrosive after 1 h of occlusive exposure, but corrosive after 4 h of occlusive exposure (van Beek, 1982). Based on the results of the read across study, the test substance, Oleyl TMAC is also considered to corrosive to skin.