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Administrative data

Description of key information

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

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
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.
Reason / purpose:
reference to same study
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.
Specific details on test material used for the study:
CYANOX® 1790 Antioxidant
IUPAC nomenclature - Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl) isocyanurate
Synonym - [tris(4-t-butyl-3-hydroxy-2,6-dimethyl-benzyl)-s-triazine-2,4,6-(1H,3H,5H) trione]

Appearance - White powder, odorless
CAS No. 40601-76-1
Molecular Formula - C42H57N3O6
Molecular Weight - 699.92 g/mole
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
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% in petrolatum for induction; 1.0% in petrolatum for challenge.
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
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
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
100
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
100
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested

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.

Interpretation of results:
GHS criteria not met
Conclusions:
There were no instances of irritation or sensitization from this material on the Draize-Shelanski Test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

A group of 100 human volunteers (61 females, 39 males, 18-50 years of age) were treated under semi-occlusive wrap with a 2.5% concentration of the test substance id white petrolatum as part of a modified Draize-Shelanski Repeat Insult Patch Test. Exposures were for 24 h on the backs or forearms of all subjects. Test material was applied on 10 alternate days and after a 7 day rest, challenge patches with 1% test material in whit petrolatum were administered for 24 h. No sensitization was reported in any test subject wither after induction (1-10 days) or after challenge (24 and 48 h).


Migrated from Short description of key information:
A HRIPT conducted on 100 human volunteers

Justification for selection of skin sensitisation endpoint:
A well conducted HRIPT study in human volunteers indicating no sensitization potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the lack of skin sensitization in a well-conducted study in human volunteers, the test material is not considered a skin sensitizer. Thus, no classification is warranted.