Benzyltrimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.

Data source

Reference

Reference Type:

other: TSCA 8e submission

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

60% solution of Benzyltrimethylammonium chloride in water

IUPAC Name:

60% solution of Benzyltrimethylammonium chloride in water

Details on test material:

Benzyltrimethyl Ammonium Chloride (60% solution in water). Lot No. 59.

Test animals

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

Albino rabbits were used. No further details provided

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 ml was applied to the skin

Duration of treatment / exposure:

24 hours

Observation period:

animals were observed at 24 and 72 hours

Number of animals:

6

Details on study design:

The test procedure was modeled after that of Draize et al.

Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit. Two test sites located lateral to the midline of the back approximately ten centimeters apart were selected. One of the two sites was abraded by making four epidermal incisions, two perpendicular to the other two, while the other test site remained intact.

The test material was applied to each of the test sites on each rabbit and occluded with gauze patches which were secured with masking tape. The trunk of each animal was then wrapped with impervious plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the 24-hour exposure period.

At the end of 24 hours, the plastic wrappings. patches, and all residual test material were removed. The intact and abraded test sites were examined
and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.


Reference:
Draize. John H., Woodard. Geoffrey, and Calvery. Herbert 0., Methods for the Study of Irritation and Toxicity of Substances .Applied Topically to
the Skin and Mucous Membranes. J. Pharm. & Exp. Ther. 82:377 (1944).

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.7

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: intact skin was fully reversible within 72 hours

Irritant / corrosive response data:

Erythema was observed on intact and abraded skin 24 hours after application of test material. No evidence of edema was noted.

Other effects:

No additional information available

Any other information on results incl. tables

Table 1 Dermal Effects following Dermal Exposure to Benzyltrimethylammonium chloride

	Irritation Scores for Abraded Skin Sites:				Irritation Scores for Intact Skin Sites at:
	24 hours		72 hours		24 hours		72 hours
Animal Number	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	1	0	1	0	1	0	0	0
2	1	0	1	0	1	0	0	0
3	1	0	0	0	1	0	0	0
4	1	0	1	0	1	0	0	0
5	1	0	1	0	1	0	0	0
6	1	0	0	0	1	0	0	0
Mean	1.0	0.0	0.7	0.0	1.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Slight dermal irritation,erythema, was observed on intact and abraded skin. While total recovery was noted on intact skin within 72 hours, some erythema was still observed after 72 hours on abraded skin. There was no evidence of edema.

Executive summary:

The dermal irritation potential of the test material was examined. Slight dermal irritation,erythema, was observed on intact and abraded skin. While total recovery was noted on intact skin within 72 hours, some erythema was still observed after 72 hours on abraded skin. There was no evidence of edema.