Trimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31. May 1967 - 05. Jun 1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (1, 5, 15 min and 20 h exposure duration, no 72 h reading, 7-d observation period, 60% aqueous solution of test substance).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(limited documentation, 1, 5, 15 min and 20 h exposure duration, no 72 h-reading, observation period 7 d, 2 animals, 60% aqueous solution of test substance)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethylammonium chloride

EC Number:

209-810-0

EC Name:

Trimethylammonium chloride

Cas Number:

593-81-7

Molecular formula:

C3H9N.ClH

IUPAC Name:

N,N-dimethylmethanaminium chloride

Details on test material:

- Name of test substance (as cited in study report): Trimethylaminhydrochlorid
- Analytical purity: approx. 60 - 65% aqueous solution
- Impurities: 0.2 - 1% Trimethylamin
- Physical state: liquid
- Subtance number: XVII/118

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.56 and 3.58 kg
no additional information given

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: other: untreated site served as control

Amount / concentration applied:

test substance (approx. 60% aqueous solution; 0.2 – 1% Trimethylamin)

Duration of treatment / exposure:

1, 5, 15 min and 20 h

Observation period:

7 d (readings after treatement: 24 h, 48 h, 5 d and 7 d)

Number of animals:

2 (females)

Details on study design:

TEST SITE
- Area of exposure: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was washed with Lutrol (conc.) and 50% in water.
- Time after start of exposure: 1, 5, 15 min or 20 h.

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(20 h exposure)

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: slight, line-like necrosis at day 5, scaling at day 7

Remarks:

This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.

Results 2

Irritation parameter:

erythema score

Remarks:

(20 h exposure)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: see 'Remarks'

Remarks:

This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.

Results 3

Irritation parameter:

edema score

Remarks:

(20 h exposure)

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: slight, line-like necrosis at day 5, scaling at day 7

Remarks:

This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.

Results 4

Irritation parameter:

edema score

Remarks:

(20 h exposure)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: see 'Remarks'

Remarks:

This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.

Other effects:

Body weights (day 0 - day 7):
animal#1: 3.58 kg - 3.36 kg
animal#2: 3.56 kg - 3.34 kg

Any other information on results incl. tables

 Table 1: Details on results: Skin irritation

Exposure	Reading	Animal#1			Animal#2
		Erythema	Edema	Remarks	Erythema	Edema	Remarks
1 min	All timepoints	0	0	-	0	0	-
5 min	All timepoints	0	0	-	0	0	-
15 min	All timepoints	0	0	-	0	0	-
20 h	24 h	3	2	-	1	0	-
	48 h	3	2	-	0	0	-
	5 d	0	0	Line-like necrosis	0	0	-
	7 d	0	0	Scaling	0	0	-
	Mean (24, 48 h)	3.0	2.0	-	0.5	0.0	-

Because of the strong differences between the 2 animals after test substance application, the assessment is based on the reaction of animal#1 in a worst case scenario.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is considered as skin-irritant. Despite of restrictions regarding the actual guideline, the study is considered suitable for assessment

Executive summary:

In a primary dermal irritation study performed according to a protocol similar to the OECD test guideline 404, the test substance (approx. 60% aqueous solution; 0.2 – 1% Trimethylamin) was applied to the intact skin of 2 rabbits (Vienna White) under occlusive conditions for 1, 5, 15 min and 20 h. Erythema (mean scores (24 – 48 h): 3.00 and 0.50) was observed, but was fully reversible within 5 d and 48 h, respectively. Edema (scores: 2.00 and 0.00) was reversible within 5 d. The scores of one animal are above the threshold of classification, thus in a worst case scenario with regard to this animal, the test substance is considered irritant. The conditions were very harsh compared to the conditions requested by the guideline (20 h instead of 4 h treatment, occlusive instead of semiocclusive treatment) and no 72 h scoring was performed. But as the test substance concentration was only 60% and a strong reaction was observed in 1 of 2 animals, an irritant potential of the test substance is assumed. Besides the observed erythema, line-like necrosis was described on day 5. As on day 7 only scaling is reported, it is not considered to be of relevance for classification.