Di-tert-butyl α,α,α',α'-tetramethyl-(p-phenylenedimethylene) diperoxide

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

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

Test material information

Constituent 1

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

IUPAC Name:

1,4-bis[1-(tert-butylperoxy)-1-methylethyl]benzene

Constituent 2

Reference substance name:

1,3(4)-bis(tert-butylperoxyisopropyl)benzene

IUPAC Name:

1,3(4)-bis(tert-butylperoxyisopropyl)benzene

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 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 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

Results

Results 1

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

Results 2

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.