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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a : GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

- Name of test material (as cited in study report): 1,3 & 1,4-di-(2-t-butylperoxyisolpropyl)benzene
- Physical state: yellow solid
- Analytical purity: 97,45 %
- Storage condition of test material: at room temperature and protected from light
- Other: an analytical certificate was provided by the Sponsor

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: 8 weeks old
- Weight at study initiation: 237-257 g (males) and 244-252 (females)
- Housing: individually (during the treatment period) in polycarbonate cages
- Diet (A04C pelleted diet) and water: ad libitum (filtred drinking water)
- Acclimation period: at least 5 days before the begining of the study

ENVIRONMENTAL CONDITIONS
- Temperature : 19-23 °C
- Humidity: 30-70 %
- Air changes : 12 per hr
- Photoperiod: 12/12 hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: Before the application, the substance was pre-moistened with 2 ml water

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 8 cm (on the day before tratment, the dorsal area of each animal was clipped using electric clippers; only animals with healthy intact skins were used for the study)
- % coverage: 10 %
- Type of wrap if used: The gauze was held in contact with the skin by mean of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage (in order to avoid the ingestion of the test substance by the animal).

TEST MATERIAL
- Amount applied: a single dose of 2000mg/kg of the test substance (fine powder) was placed on an hydrophilic gauze pad pre-moistened with 2 ml of water and the applied to the skin.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently during the hours following administration of test substance, then at least once a day until day 15. Body weight were recorded just before the administration of test substance on day 1, then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: a macroscopic examination of the main organs (digestive tract, heart, kidney, liver, lungs, pancreas, spleen and any organ with obvious abnormalities was performed)

Statistics:

not appropriate

Results and discussion

Preliminary study:

No preliminary study because the substance was anticipated to be non-toxic at 2000 mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality.

Clinical signs:

other: No clinical signs and no cutaneous reactions were observed during the study.

Gross pathology:

No abnormal observations.

Other findings:

No other relevant findings.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: other: Directive 67/548/EEC, and EU Regulation (EC) N0. 1272/2008 (CLP)

Conclusions:

Under these experimental conditions, the dermal LD50 of Peroximon F is assumed to be more than 2000 mg/kg in Sprague Dawley rats.

Executive summary:

The acute dermal toxicity of Perximon F ( 1,3 & 1,4-di-(2-t-butylperoxyisolpropyl)benzene) was evaluated in rats according to OECD N° 402 guideline and EC 92/69/EEC B.3 guidelines (Acute Toxic Standard Method). Peroximon F was applied to the skin of groups of 5 male and 5 female Sprague Dawley rats at doses of 2000 mg/kg in a semi-occlusive dressing for 24 hours. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14).

No mortality and no abnormal clinical signs were observed. Only a slight bodyweight loss was seen in 4/5 females between day 1 and day 8. At necropsy, no abnormal gross pathology was observed.

Under these experimental conditions, the dermal LD50 of Peroximon F is assumed to be more than 2000 mg/kg in Sprague Dawley rats.