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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:
1991-07-09 to 1991-07-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary non-guideline study, the study was not conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
There is no information on test material, on animals (such as housing conditions, strain, age, weight, source etc). There is no indication as to whether or not the test article was removed after instillation. It was not indicated as to whether or not the test article was ground as a fine dust when placed in the conjunctival sac.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No information available.

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No further information available.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Single administration of test substance to eye
Observation period (in vivo):
The eye of the rabbit was examined at 1 and 24 hours after application
Number of animals or in vitro replicates:
1 male rabbit
Details on study design:
0.1 g of test material was applied to the right eye of 1 male rabbit, the left eye remained untreated to serve as a control. In the interests of animal welfare, only 1 male rabbit was used as it was assumed that trimellitic anhydride would be a severe eye irritant.
The eye irritation was scored according to the Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 hour
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hour
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Signs of ocular irritation were maximum at 24 hours after application and the study was terminated immediately thereafter.
Other effects:
No other effects reported.

Any other information on results incl. tables

Table 1: Summary of eye irritation scores in one male rabbit

Time

Cornea

Iris

Conjunctiva

 

Density of opacity

Area of opacity

 

Erythema

Chemosis

Discharge

1 hour

4

4

2

2

3

2

24 hour

4

4

2

3

4

3

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Trimellitic acid (TMA) is considered a severe eye irritant. TMA is classified as irritating with the symbol Xi and is assigned the risk phrase R41 " Risk of serious damage to eyes" according to Regulation (EC) No 1272/2008. It is classified as Category 1 for serious eye damage with the signal word "Danger" and is assigned the hazard statement H318 "causes serious eye damage" according to Regulation (EC) No 1272/2008
Executive summary:

The study investigated the eye irritant effects of the test material in 1 male rabbit. 0.1 g of trimellitic anhydride was administered to the right eye of one male rabbit. The left eye served as the untreated control. The treated eye was examined at 1 and 24 hours after application of the test material. The control eye was used for comparison.

Signs of ocular irritation were maximum at 24 hours after application and the study was terminated immediately thereafter. On this basis, trimellitic anhydride is considered a severe eye irritant. TMA is classified as irritating with the symbol Xi and is assigned the risk phrase R41 " Risk of serious damage to eyes" according to 67/548/EEC. It is classified as Category 1 for serious eye damage with the signal word "Danger" and is assigned the hazard statement H318 "causes serious eye damage" according to Regulation (EC) No 1272/2008