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

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 26, 1976

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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Remarks:

Clear water-white viscous liquid

Specific details on test material used for the study:

Test material: (Alkyl(C12-C18)dimethylethylbenzylammonium chloride as a.i.) in aqueous solution
Lot/Batch number: Notebook #1607-3684; Sample #676-09/L
Study no: 7677-7
Description: Clear water-white viscous liquid
Purity: 50% w/w a.i.
Stability: The a.i., ADEBAC, is hydrolytically and photolytically stable under the conditions of this study and its related quaternary ammonium compounds have 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:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight: 1.5-3 kg bw
Animals were maintained under standard laboratory conditions for a minimum of seven days, prior to the administration of the test substance

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dose route: Topical occluded; abraded skin

Duration of exposure:

Post exposure period: 24 hours with test substance, 14 days after removal of dressing

Doses:

0.5, 1.0, 2.0, 2.52, 3.96 g a.i./kg bw

No. of animals per sex per dose:

5/group (mixed sex)

Control animals:

no

Details on study design:

Examinations made:
Clinical signs: Yes
Mortality: Yes
Bodyweight: Yes
Other examinations: A complete gross necropsy was performed on all animals

Statistics:

The LD50 together with 95% confidince limits was determined, where possible, by the method of Litchfield and Wilcoxin (1949): Acute Toxicity, J. Pharm. Exp. Ther., 96-99.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 300 mg/kg bw

Based on:

act. ingr.

95% CL:

ca. 1 460 - ca. 3 630

Mortality:

Refer the table 1

Clinical signs:

Depression was noted in 1 an 2 animals in the 2000 and 3960 mg a.i./kg dose groups, respectively.

Body weight:

Refer the table 2

Gross pathology:

Gross necropsy observations were recorded; however no consistent findings were noted.

Any other information on results incl. tables

Mortality: Table - 1

Dose levels (g/kg)	Mortality (# Dead/# Dosed)	% mortality
0.5	0/5	0
1.0	1/5	20
2.0	3/5	60
2.52	2/5	40
3.96	2/8	40

Body weight: Table - 2

Dose levels (g/kg)	Animal #	Bodyweight (kg)
		Initial	Final
0.5	1	2.59	2.94
	2	2.19	2.56
	3	1.76	1.92
	4	2.37	2.52
	5	1.72	1.49
1.0	1	1.68	1.78
	2	1.82	1.86
	3	2.15	1.98
	4	2.15	2.17
	5	1.96	1.62
2.0	1	2.28	1.49
	2	2.13	2.00
	3	1.80	1.43
	4	1.37	1.73
	5	1.71	1.12
2.52	1	2.14	1.88
	2	1.66	1.42
	3	1.44	1.62
	4	1.77	1.78
	5	2.20	1.30
3.96	1	1.96	1.25
	2	2.41	2.25
	3	1.89	1.52
	4	2.11	1.29
	5	1.63	1.35

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on EU CLP criteria

Conclusions:

Under study conditions, the LD50 of the test substance was determined to be 2300 mg a.i./kg

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, C12-18 ADEBAC (active: 50%), according to the method described by Hagan et al 1959 (Acute Toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 17-25, 1959) and similar to the OECD 402 guideline. A total of twenty-five rabbits were used to conduct the study. Each rabbit was given a single dose of the test substance at dose levels ranging from 500 to 2960 g a.i./kg bw. Applications were made to the skin, mildly shaved and abraded under 1”x1” gauze patches over 10% of the body surface. After dosing, the sites were covered with an impermeable plastic wrapping for 24 h. After removal of the dressing, the test sites were gently cleansed and the animals were observed for 14 d for toxic effects. Depression was noted in 1 an 2 animals in the 2000 and 3960 mg a.i./kg bw dose groups, respectively. Gross necropsy observations were recorded, however no consistent findings were noted. Under study conditions, LD50 for the test substance was determined to be 2300 mg a.i./kg bw with 95% confidence limits of 1460 to 3630 mg/kg bw. (Palanker 1976).