1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study performed under GLP-like quality controlled conditions with QAU statement included.

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

other: Pirbright White (Tif: DHP)

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln , Switzerland
- Age at study initiation: 10 weeks
- Weight at study initiation: 329 to 423 g
- Housing: individually
- Diet: ad libitum standard guinea pig pellets - NAFAG No.846, Gossau SG
- Water: ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%):30 -70
- Photoperiod (hrs dark / hrs light): 12/12

Route:

intradermal and epicutaneous

Vehicle:

other: sesame oil (for injections) or vaseline (for dermal application)

Concentration / amount:

1% for intradermal injections
30% for dermal application

Route:

epicutaneous, occlusive

Vehicle:

other: sesame oil (for injections) or vaseline (for dermal application)

Concentration / amount:

1% for intradermal injections
30% for dermal application

No. of animals per dose:

10 (5 males and 5 females)

Details on study design:

First Induction, intradermal application:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test compound in sesame oil
- test compound in the adjuvant saline mixture

Second lnduction, epidermal application:
One week later the test substance was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours). The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application). Dose of application: approx. 0.4 g paste of 3 0% test substance in vaseline

Challenge:
Two weeks after the epidermal induction application the animals were tested on the flank with the test substance in vaseline and the vehicle alone ( patch 2 x 2 cm; occluded administration for 24 hours). Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale . A second evaluation was made 48 hours after removing the dressings.

Challenge controls:

A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

30 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

30 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

30 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

30 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test item is considered to be "not sensitizing" in the guinea pig maximaization test.

Executive summary:

20 guinea pigs were induced with the test substance by intradermal injections and dermal applications according to OECD guideline no. 406. 10 control animals were induced with the vehicle only. Both groups were challenged with the test article by dermal application, and the skin reactions were evaluated 24 and 48 hours after removing of the challenge dressing. Under the experimental conditions employed, 0% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. The test substance is therefore regarded as not sensitizing.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
Result determined using data from Guinea Pig maximisation test data. The substance is non sensitising

Justification for selection of skin sensitisation endpoint:
Result determined using OECD test guideline 406

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the data available the substance does not trigger any of the requirements for classification.

The registered substance is therefore not classified.