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Toxicological information

Eye irritation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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.
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.
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.
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.
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.
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.
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.
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.