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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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.