Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-01-02 to 2008-03-03
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- form: flake
- batch: T71241
- re-test analysis: 2008-03-22
- storage: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle – France), were used after an acclimatisation period of at least five days. At the beginning of the study, the animals of the treated group weighed between 225 g and 240 g (males) and between 199 g and
212 g (females) and were 6-8 weeks old.
During the treatment, the animals were kept in individual cage. At D3, the animals were put into their cage by 2 or 3. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 20 °C and 23 °C
- relative humidity : between 32 % and 62 %
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
paraffin oil
Details on dermal exposure:
Animals from the treated group received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of the product, diluted in liquid paraffin under a volume of 10 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed.
Animals from Control Group received in the same experimental conditions the control item (distilled water) under a volume of 2 mL/kg body weight.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw in 10 ml/kg bw
No. of animals per sex per dose:
Control group: 5 male and 5 female rats
Treated group (1 dose): 5 male and 5 female rats
Control animals:
yes
Details on study design:
- 2 groups of rats: 10 controls (treated with distilled water) and 10 treated animals (2000 mg/kg bw)
- topical application, under porous gauze dressing for 24 hours
- after gauze dressing removal, clinical observation 1, 3 and 5 hours and each day for 14 days
- weight evolution 2, 7 and 14 days after the topical application
- autopsy at the end of the study, Day 14 and macroscopic observations of the main organs.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test product is higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test product must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not be classified in category 4. No signal word and hazard statement are required.
Executive summary:

The test product was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987 and the test method B.3 of the directive. n° 92/69/EEC. No mortality occurred during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test product is higher than 2000 mg/kg body weight by dermal route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test product must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not be classified in category 4. No signal word and hazard statement are required.