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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older, reasonably well-conducted study for the period, but no GLP or guideline followed. 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:
No current guideline followed; the modified Draize-Shelanski Repeat Insult Patch Test was conducted.
GLP compliance:
no

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

Test animals

Species:
human
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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: No details on test site preparation
Vehicle:
other: white petrolatum
Controls:
no
Amount / concentration applied:
2.5 %
Duration of treatment / exposure:
24 hours
Observation period:
On removal of the patch to 24 hours thereafter.
Number of animals:
100 adult human beings
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.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: score range
Time point:
other: 1-10 days after induction and at 24 and 48 hr after challenge
Score:
0
Remarks on result:
other: all subjects had scores of 0
Irritant / corrosive response data:
All subjects had scores of 0 at 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.