Trimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye 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 (limited documentation, 0.05 mL application amount, no 72 h scoring, 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(limited documentation, application amount 0.05 mL, no 72 h scoring)

Principles of method if other than guideline:

Method: BASF-Test

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 / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.07 and 3.04 kg

no additional information given

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye served as control (NaCl-treated)

Amount / concentration applied:

0.05 mL

Duration of treatment / exposure:

one single application

Observation period (in vivo):

5 and 7 d (readings after treatment: 10 min, 1 h, 3 h, 24 h, 48 h, 5 d (and 7 d))

Number of animals or in vitro replicates:

2 (1 male, 1 female)

Details on study design:

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

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(out of two animals)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

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 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(out of 2 animals)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

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:

iris score

Basis:

animal #1

Remarks:

(out of 2 animals)

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.

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(out of 2 animals)

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.

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 5 days

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 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

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 7

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(out of 2 animals)

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.

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(out of two animals)

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.

Irritant / corrosive response data:

Increased secretion 10 minutes after application in both animals.
Smeary secretion 3 h after application in both animals.

Any other information on results incl. tables

 Table 1: Details on results: Eye irritation

Reading	Animal#1				Animal#2
	Cornea	Iris	Conj.	Chemosis	Cornea	Iris	Conj.	Chemosis
10 min	1	0	2	3	1	0	1	3
1 h	1	0	2	3	1	0	2	3
3 h	1	0	2	3	1	0	2	3
24 h	1	0	1	0	1	0	2	0
48 h	1	0	1	0	1	0	2	0
5 d	0	0	0	0	1	0	2	0
7 d	-	-	-	-	0	0	0	0
Mean (24, 48 h)	1.0	0.0	1.0	0.0	1.0	0.0	2.0	0.0

Conj.: conjunctivae score

Although no 72 h scoring was performed, an overestimation of the effects is not assumed because only 0.05 mL was applicated and the test substance was not pure but 60 - 65% in water.

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

Single application of test substance caused irritating reactions in rabbits eye. Although the current guideline requires that 0.1 mL of the undiluted test substance should be evaluated in 3 animals, the study is considered suitable for assessment.

Executive summary:

The eye irritation potential of the test substance (approx. 60% aqueous solution; 0.2 – 1% Trimethylamine) was determined in a procedure similar to that described in the OECD test guideline 405. A single application of 0.05 mL of the undiluted test substance caused irritating reactions in the eyes of 2 rabbits. The effects on cornea (mean score: 1.00) and conjunctivae (mean score: 1.00 and 2.00) were reversible within 7 d, respectively.