Quaternary ammonium compounds, C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides

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

Test material information

Constituent 1

Specific details on test material used for the study:

- Analytical purity: >93%
- 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

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Intact and abraded skin site

Basis:

mean

Time point:

other: 24h and 72h

Score:

ca. 6.29

Max. score:

8

Reversibility:

not fully reversible within: 72h

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

Intact skin site

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3.33

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Results 3

Irritation parameter:

erythema score

Remarks:

Abraded skin site

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3.5

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Results 4

Irritation parameter:

edema score

Remarks:

Intact skin site

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.66

Max. score:

3

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

Results 5

Irritation parameter:

edema score

Remarks:

Abraded skin site

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: responses were not scored at 48 h

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 1 (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 (active ingredient: >93%), 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).