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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: white coarse powder
- Analytical purity: 40 %, range meta/para not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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 and abraded skin
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 rabbits per group (abraded and unabraded test groups); closed patch technique was used.
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:
other: at 4 hours, 28 hours, 52 hours, 76 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Only one animal had a score of 1 at 28 hours; all the other scores at all the time point and for all the animals were 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hours, 28 hours, 52 hours, 76 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
The undiluted test substance is not a primary skin irritant

Any other information on results incl. tables

MEASURED ENDPOINT/INDEX (i.e. LD50, PII): Test material
produced very slight erythema and was not considered a
primary dermal irritation.

There was not dermal irritation after 4 hours of contact.
After 28 hours there was very slight erythema (grade 1) on abraded sites, but cleared by 52 hours. There was no edema
and no irritation observed on intact skin sites.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU directive 67/548/EEC and EU Regulation (EC) N0. 1272/2008 (CLP):
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.