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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No clinical signs and no cutaneous reactions were observed during the study.
Body weight:
A slight bodyweight loss was seen in 4/5 females betwwen day 1 and day 8.
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.