2,4,6-trinitrobenzene-1,3,5-triamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

purity of test substance; acclimation period, details on test animals and housing/feeding conditions not reported; eyes were washed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

purity of test substance; acclimation period, details on test animals and housing/feeding conditions not reported; eyes were washed

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-trinitrobenzene-1,3,5-triamine

EC Number:

221-297-5

EC Name:

2,4,6-trinitrobenzene-1,3,5-triamine

Cas Number:

3058-38-6

Molecular formula:

C6H6N6O6

IUPAC Name:

trinitrobenzene-1,3,5-triamine

Test material form:

not specified

Details on test material:

- Name of test material as cited in the report: TATB ; 1,3,5-triamino-2,4,6-trinitrobenzene
- Lot/batch No.of test material: B-318

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

Test substance was washed from the eye of six rabbits (30 seconds after instillation in three rabbits; 5 minutes after instillation in another three rabbits); and no washing was done in three rabbits.

Observation period (in vivo):

1, 4, 24, 48, 72, 96 hours and 7 days after instillation of test substance

Number of animals or in vitro replicates:

9 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test substance was washed from the eye of six rabbits (30 seconds after instillation in three rabbits; 5 minutes after instillation in another three rabbits); and no washing was done in three rabbits.

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Results 1

Remarks on result:

other: See "Any other information on results incl. tables"

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Irritant / corrosive response data:

Irritation was observed in conjunctival and iris tissues only. All three rabbits in the no-wash and 5 minute wash groups showed circumcorneal injection around the iris at the 1-hour reading. This condition persisted for 3 days in the no-wash group. Occasional circumcorneal injection responses were noted in individual rabbits at all treatment levels, but all effects involving the iris had disappeared by day 4 after treatment.
Conjunctival responses were observed at all treatment levels and generally involved mild redness, chemosis, and discharge. The treated eye of all rabbits in the 30-second wash group had returned to normal within 24 hours, whereas the treated eye of rabbits in the 5-minute wash group did not completely clear until day 4, and the no-wash group was not judged normal in response until day 7. Overall, the degree of eye irritation caused by test substance was mild but transitory.

Any other information on results incl. tables

Table 7.3.2/1: Summary of eye irritation responses in rabbits treated with test substance (three rabbits per wash condition)

 

Tissues graded*	Average Irritancy Score
	Hours		Days
	1	4	1	2	3	4	7
30 Seconds washing
Cornea	0	0	0	0	0
Iris	0	1.7	0	0	0
Conjunctivae	5.3	4.0	0	0	0
5 minutes washing
Cornea	0	0	0	0	0
Iris	5.0	0	0	1.7	0
Conjunctivae	1.7	2.7	2.0	2.0	0.7	0
No wash
Cornea	0	0	0	0	0	0	0
Iris	5.0	1.7	1.7	1.7	1.7	0	0
Conjunctivae	4.0	2.7	1.3	0.7	0.7	0.7	0

 

*Maximum corneal response: 80; Maximum iris response: 10; Maximum conjunctivae response: 20

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was mild but transitory irritant to the eyes of rabbits.

Executive summary:

In an eye irritation study, 0.1 g of test substance was instilled into the left eye of 9 New Zealand White rabbits while the right eye remained untreated and served as control. Test substance was washed from the eye of six rabbits (30 seconds after instillation in three rabbits; 5 minutes after instillation in another three rabbits); and no washing was done in three rabbits. Animals were observed at 1, 4, 24, 48, 72, 96 h and 7 days after instillation of test substance.

Irritation was observed in conjunctival and iris tissues only. All three rabbits in the no-wash and 5 minute wash groups showed circumcorneal injection around the iris at the 1-hour reading. This condition persisted for 3 days in the no-wash group. Occasional circumcorneal injection responses were noted in individual rabbits at all treatment levels, but all effects involving the iris had disappeared by day 4 after treatment. Conjunctival responses were observed at all treatment levels and generally involved mild redness, chemosis, and discharge. The treated eye of all rabbits in the 30-second wash group had returned to normal within 24 hours, whereas the treated eye of rabbits in the 5-minute wash group did not completely clear until day 4, and the no-wash group was not judged normal in response until day 7. Overall, the degree of eye irritation caused by test substance was mild but transitory.

Under the test conditions, the test substance was mild but transitory irritant to the eyes of rabbits.