Benzyl-C12-14-alkyldimethylammonium chlorides

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

1. In the study, 4 animals/sex/test group were used; however, the guideline recommends 5 animals of one sex in each test group. 2. Abraded and non abraded skin sites were used; however, guideline recommends unabraded skin. 3. Gross necropsy was not perfor

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

EC Number:

270-325-2

EC Name:

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

Cas Number:

68424-85-1

Molecular formula:

C12-14H25-29-(CH3)2-C6H5-N.CL

IUPAC Name:

Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
- Weight at study initiation: 2.2 – 3.4 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test site
- Area of exposure: Back of animal (10% of body surface)
- Type of wrap if used: The test sites were covered with gauze and each animal was wrapped in a sleeve after application of the test substance
- Type of test site: Intact and abraded (half of the test animals in each sex, i.e., 2 animals/sex/group had their skin abraded on one side )

Removal of the test substance
- Washing (if done): After removal of the dressing, animals were washed with warm water and dried.
- Time after start of exposure: After 24h

Test material
- Amount(s) applied (volume or weight with unit): 3,4 and 5 mL/kg bw
- Concentration (if solution): Undiluted (as received)
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

3,4 and 5 mL/kg bw

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14d
- Frequency of observations and weighing: The animals were observed for clinical signs, mortality and body weight (at the start of the experiment and at termination (Day 14)).
- Necropsy of survivors performed: No

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3.56 mL/kg bw

Based on:

test mat.

95% CL:

>= 3.01 - <= 4.2

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 730 mg/kg bw

Based on:

act. ingr.

Mortality:

Mortality observed at each dose levels:
3 mL/kg bw: 1/8
4 mL/kg bw: 6/8
5 mL/kg bw: 7/8

For details please refer to the attachment under 'Attached background material'

Clinical signs:

other: Severe erythema and oedema was observed post dosing at the sites of application for all animals in all groups. In the 3 mL/kg bw dose group (i.e., surviving animals), the erythema was followed by thickening of the skin and eschar formation across the back

Any other information on results incl. tables

Table 1:

Dose levels (ml/kg)	Mortality	Time to mortality
5 0	7/8	1, 2, 7 & 12 days
4.0	6/8	2, 3, 4 & 6 days
3.0	1/8	9 days

Table 2:

Dose levels (ml/kg)	Animal #	Bodyweight (kg)
		Initial	Final
5	58	2.3	2.0
4	57A	2.8	2.7
	61A	2.8	2.6
3	57B	3.0	2.6
	58B	2.7	2.1
	59B	3.2	3.1
	60B	2.7	2.4
	61B	2.6	2.4
	63B	2.3	1.6
	64B	2.6	2.0

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Under the conditions of the study, the acute dermal LD50 of the test substance was found to be 3.56 mL/kg bw (95% c.i.- 3.01 - 4.20 mL/kg bw). After correcting for 80%purity of the active substance, the LD50 was calculated to be 2730 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, C12-16 ADBAC (80% active in water), according to a method similar to EPA OPPTS 870.1200. The experiment was performed in rabbits. The test substance was applied to twelve male and twelve female rabbits (4 animals/sex/test group) at dose levels of 3, 4 and 5 mL/kg bw (single application) on the abraded and intact skin of the back. The test sites were covered with gauze and each animal was wrapped in a sleeve after application for a 24 h period. After removal of the dressing, animals were washed with warm water and dried. The animals were observed for clinical signs and mortality for 14 d. Body weights were determined at the start of the experiment and at termination (Day 14). In the study, 1/8, 6/8 and 7/8 animals died at 3, 4 and 5 mL/kg bw, respectively. Decreases in bodyweight were observed in all surviving animals in all treatment groups.Severe erythema and oedema at site of application observed post dosing for all animals in all groups. In the 3 mL/kg dose group (i.e. surviving animals), the erythema was followed by thickening of the skin and eschar formation across the back. Under the conditions of the study, the acute dermal LD50 of the test substance is considered to be 3.56 mL/kg bw (95% c.i.- 3.01 - 4.20 mL/kg bw). After correcting for 80% purity of the active substance, the LD50 is calculated to be 2730 mg a.i./kg bw (Levenstein, 1977).