1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

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:

other: Recognized method of the period, but not following current guideline or GLP. The scoring system was not described.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Modified Draize-Shelanski Repeat Insult Patch Test

GLP compliance:

no

Type of study:

other: modified Draize-Shelanski Repeat Insult Patch Test

Justification for non-LLNA method:

The test was done before the requirements for a LLNA test.

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

EC Number:

254-996-9

EC Name:

1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Cas Number:

40601-76-1

Molecular formula:

C42H57N3O6

IUPAC Name:

tris[(4-tert-butyl-3-hydroxy-2,6-dimethylphenyl)methyl]-1,3,5-triazinane-2,4,6-trione

Constituent 2

Reference substance name:

Cyanox (TM) 1790 Antioxidant

IUPAC Name:

Cyanox (TM) 1790 Antioxidant

Test material form:

solid: particulate/powder

In vivo test system

Test animals

Species:

human

Strain:

other: See details on human subjects

Sex:

male/female

Details on test animals and environmental conditions:

One hundred healthy adults (61 females, 39 males, 18-50 years of age, 58 black, 2 Puerto Rican, 40 white) served as subjects for the study

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Induction 2

Concentration / amount:

2.5% in petrolatum for induction; 1.0% in petrolatum for challenge.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

2.5% in petrolatum for induction; 1.0% in petrolatum for challenge.

No. of animals per dose:

100

Details on study design:

A 15 mm patch of test material (2.5% in white petrolatum) was applied to patch sites on the backs or volar forearms of the subjects for 10 alternate-day 24 hour periods under occlusion. Following a seven day test period (in which subjects were evaluated daily), 15 mm challenge patches (1.0% in white petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter.

Challenge controls:

untreated skin areas.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

100

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

100

Results 3

Group:

negative control

Remarks on result:

not measured/tested

Results 4

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

All subjects had scores of 0, 1-10 days after induction and 24 and 48 hours after challenge. The material was therefore neither irritating nor sensitizing.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no instances of irritation or sensitization from this material on the Draize-Shelanski Test.