Registration Dossier

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:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide
EC Number:
213-944-5
EC Name:
Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide
Cas Number:
1068-27-5
Molecular formula:
C16H30O4
IUPAC Name:
2,5-bis(tert-butylperoxy)-2,5-dimethylhex-3-yne
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: the test compound was received from Lucidol Division, Wallace and Tiernan, Inc.
- Weight at study initiation: 1729 to 2504 g
- Housing: All animals were placed in holders designed to immobilize the animal

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied:0.5 mL/rabbit
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
twelve albino rabbits (two groups of 6 animals)
Details on study design:
TEST SITE
- Area of exposure: Approximately one inch square on each site of the back of the animals.
- Type of wrap if used: The rabbits were further prepared following application by placing a piece of rubber dam 2x2 inches over each area of application. The damming was held in place with adhesive tape and the entire trunk of each animal wrapped with rubberized cloth bandage to hold the patches in place and retard the evaporation of volatile substance.

REMOVAL OF TEST SUBSTANCE
- Washing: The back of each rabbit was washed with lukewarm water
- Time after start of exposure: 24 hours

READINGS: The areas of compound application were exermined after 24 hours and 72 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained in this study, the test substance does not possess any primary irritating properties to the skin of albino rabbits under the test conditions chosen.
Executive summary:

The test substance was applied once only at a total volume of 0.5 mL/rabbit to the prepared dermal surface of the back of albino rabbits. On the basis of the results obtained in this study, the test substance dies not possess any primary irritating properties to the skin of this species under the test conditions chosen (mean erythema score and mean edema score = 0).