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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

purity of test substance; acclimation period, details on test animals/environmental conditions, detailed test procedure and results not reported

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 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

purity of test substance; acclimation period, details on test animals/environmental conditions, detailed test procedure and results not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

At the time of study completion (1976), the LLNA was not available.

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

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 300-400 g
- Housing: Animals were housed individually
- Diet: Commercial laboratory ration supplemented on alternate days with fresh lettuce or cabbage, ad libitum

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1%

Concentration / amount:

0.1%
1st injection of 0.05 mL; other 9 injections of 0.1 mL (10 injections)

Day(s)/duration:

2 weeks

Challenge

No.:

#1

Route:

intradermal

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1%

Concentration / amount:

0.05 mL

Day(s)/duration:

24 hours

No. of animals per dose:

10 animals

Details on study design:

PRE-TREATMENT: Before each injection, the test site was clipped free of hair with electric small-animal clippers.

INDUCTION EXPOSURE
Test substance was administered in a series of ten "sensitising" injections into the lower back and flanks of the guinea pigs. Injections were made randomly over the test area every other day using tuberculin syringe. The volume of the first injection was 0.05 mL; the other nine injections were each 0.1 mL. Twenty-four hours after each injection, the resulting reaction was scored for redness, height, and diameter. Redness and height were scored as described by Draize method; diameters of reactions were measured in millimeters using micrometer calipers.

CHALLENGE EXPOSURE
Two weeks after administration of the tenth sensitising injection, the lower back and flanks of each experimental guinea pig were clipped free of hair, and a challenge injection of 0.05 mL was administered. Each animal's reactions were graded 24 hours later and compared with those from the sensitizing injections.

Challenge controls:

None

Positive control substance(s):

not specified

Results and discussion

Positive control results:

None

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.1%

No. with + reactions:

0

Clinical observations:

None

Remarks on result:

no indication of skin sensitisation

Results 3

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance is not classified as skin sensitiser, therefore it is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a skin sensitisation study, the test substance was administered to group of male Hartley guinea pigs as induction and challenge phase. Test substance was diluted to a concentration of 0.1% with a 1% solution of carboxymethylcellulose. The control group received the 1% solution or of carboxymethylcellulose alone.

 

Induction phase: Test substance was administered in a series of ten "sensitising" injections into the lower back and flanks of the guinea pigs. The volume of the first injection was 0.05 mL; the other nine injections were each 0.1mL. Twenty-four hours after each injection, the resulting reaction was scored for redness, height, and diameter.

 

Challenge phase: Two weeks after administration of the tenth sensitising injection, the lower back and flanks of each experimental guinea pig were clipped free of hair, and a challenge injection of 0.05 mL was administered. Each animal's reactions were graded 24 hours later and compared with those from the sensitizing injections.

 

No skin sensitization reactions were observed in the treated animals.

 

Under the test conditions, the test substance is not classified as skin sensitiser, therefore it is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.