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Diss Factsheets

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
1. In the study, abraded and non abraded skin sites were used; however, the guideline recommends unabraded skin. 2. Exposure period was 24 h; however, guideline recommends 4 h exposure period
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
EC Number:
939-253-5
Molecular formula:
C12-16H25-33-(CH3)2-C6H5-N.CL
IUPAC Name:
Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
Test material form:
liquid
Specific details on test material used for the study:
- Analytical purity: The purity of the a.s. is typically >93% ADBAC as described in Section 2; the a.s. is supplied in aqueous/alcohol solution of 50% or 80% a.s. Doses are based on a.s. (i.e. corrected for the dilution in alcohol/water)
- Stability under test conditions: The test substance is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least five years under standard laboratory conditions.

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The test substance was applied to both abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Test material
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
24h
Observation period:
24 and 72h
Number of animals:
6
Details on study design:
Test site:
- Area of exposure: Back of animal
- Type of wrap if used: The patches consisted of two layers of light gauze cut in squares (2.5 cm on the side). The patches were secured to the test area by thin bands of adhesive tape and the trunk of each animal was wrapped in clear plastic trunk bands after application of the test substance.
- Type of test site: Two areas (intact and abraded) on the back of each animal placed approximately 10 cm apart

Scoring system:
- Skin reactions were scored for erythema and edema, according to Draize Woodland and Calvery scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h and 72h
Score:
6.29
Max. score:
8
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Intact and abraded skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Intact skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Abraded skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
2.66
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Intact skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Abraded skin site
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
ca. 3.5 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3.5 for intact and 4 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 / 72 h
Score:
ca. 3 - ca. 3.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3.5 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 / 72 h
Score:
ca. 3.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3.5 for intact and 3.5 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 / 72 h
Score:
ca. 3.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3.5 for intact and 3.5 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 / 72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3 for abraded skin)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 / 72 h
Score:
ca. 3.5 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 4 for intact and 3.5 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 / 72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 / 72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24/72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 3 for intact and 3 for abraded skin)
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
ca. 2.5 - ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Remarks:
(mean erythema score was: 2.5 for intact and 3 for abraded skin)
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
other: see below table for details on results
Irritation parameter:
edema score
Time point:
24/48/72 h
Remarks on result:
other: see below table for details on results
Irritant / corrosive response data:
- Severe erythema and edema were observed in animals with abraded and intact skin. See below table for individual animal scores at each time point.

Any other information on results incl. tables

Table 1. Individual animal data on the skin irritation response

Rabbit no.

Reaction

24 h

72 h

Intact

Abraded

Intact

Abraded

1

Erythema

4

4

3

4

Edema

2

3

3

3

2

Erythema

3

4

3

3

Edema

2

3

3

3

3

Erythema

4

4

3

3

Edema

3

3

3

3

4

Erythema

4

4

3

3

Edema

2

3

3

3

5

Erythema

3

3

3

3

Edema

3

3

3

3

6

Erythema

4

4

4

3

Edema

2

3

3

3

 

Applicant's summary and conclusion

Interpretation of results:
other: Category 1B (corrosive) based on CLP criteria
Conclusions:
Based on the results of the study, the test substance is considered to be corrosive to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the test substance, C12 -16 ADBAC (50 -80% active), according to US EPA OPPTS 870.2500. The experiment was performed in rabbits. The undiluted test substance was applied on intact and abraded skin sites using occlusive patches for an exposure period of 24 h. The skin was then observed for erythema and edema formation and the scoring was done according to the Draize, Woodland and Calvery scoring system at 24 and 72 h from the onset of exposure. Severe erythema and edema were observed in all the test animals at both the abraded and intact sites. The mean Primary Irritation Index (PII) of the test substance was calculated to be 6.29 and the mean values of erythema and edema were 3.33 (intact skin site), 3.5 (abraded skin site), 2.66 (intact skin site) and 3 (abraded skin site). Based on the results of the study, the test substance is considered to be corrosive to rabbit skin (Wallace, 1975).