Benzene-1,2,4-tricarboxylic acid 1,2-anhydride

Eye irritation

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

Test material information

Constituent 1

Reference substance name:

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride

EC Number:

209-008-0

EC Name:

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride

Cas Number:

552-30-7

Molecular formula:

C9H4O5

IUPAC Name:

1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 hour

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hour

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 hour

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 hour

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hour

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 8

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