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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
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

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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% in petrolatum for induction; 1.0% in petrolatum for challenge.
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

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.