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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
january 13, 1986 to january 16, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted in accordance with a recognized scientific procedure for analyzing the primary dermal irritation of a test material in experimental animals. However, the test material was a solid and was not pre-moistened. The test was performed on a 40% formulation. Study details were sufficient to support the conclusions in the report regarding the dermal irritation toxicity of the formulated test material. However, they are not sufficient to identify the dermal irritation potential of the more pure form of Bis (t-butyl peroxyisopropyl) benzene.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: EEC Directive 79-831, Annex V, part B: Methods for the determination of toxicity, B.4. Acute toxicity, skin irritation, date December 1983
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide
EC Number:
246-678-3
EC Name:
[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide
Cas Number:
25155-25-3
Molecular formula:
C20H34O4
IUPAC Name:
Reaction mass of 1,3-bis[2-(terbutylperoxy)propan-2-yl]benzene and 1,4-bis[2-(terbutylperoxy)propan-2-yl]benzene
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Weight at study initiation: 2500-3500 g
- Housing: individually in galvanised cages
- Diet : ad libitum
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature : 15-21 °C
- Humidity: 40-70 %
- Air changes : 10 per hour
- Photoperiod : 12 hrs dark /12 hrs light):

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
76 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch diameter
- Type of wrap if used: impervious material

SCORING SYSTEM:
- The skin reaction were evaluated by the method of Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The undiluted test substance is not a primary skin irritant

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test material is not considered as a primary dermal irritant.
Executive summary:

The acute dermal irritation of the peroxide was evaluated in rabbits according to OECD 404 guideline. The substance was applied undiluted and not pre-moistened to the skin of 6 New-Zealand White albino rabbits and held in contact for 4 hours by means of an occlusive dressing. No irritation was observed. Under the experimental conditions, the substance was considered as non irritant when applied topically in rabits.