Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-11-27 to 2008-01-15
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:
yes
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): LCE07104
- Physical state: solid, pearl
- Analytical purity: 100%
- Lot/batch No.: T71225
- Expiration date of the lot/batch: 21 March 2009 (re-test)
- Storage condition of test material: at the room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals:
Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle– France), an acclimatisation period of at least five days was performed. At the beginning of the study, the animals of the treated group weighed between 228 g and 246 g (males) and between 198 g and
220 g (females) and were 7-8 weeks old.
Group 1 (control): 5 male rats and 5 female rats
Group 2 (treated): 5 male rats and 5 female rats
Housing:
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 19 °C and 22 °C
- relative humidity : between 34 % and 52 %
- lighting time: 12 hours daily

- drinking water (tap water form public distribution system) and foofstuff 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).

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
-Animals from Group 2 received by topical application (10% of area body), under porous gauze dressing, an effective dose
of 2000 mg/kg body weight of th substance, diluted in distilled water under a volume of 10 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated areas were rinsed with distilled water.
Animals from Group 1 received in the same experimental conditions the control item (distilled water) under a volume of 2 mL/kg body weight.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw
- Concentration : 10ml/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24 hours exposure
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male rats
5 female rats
Control animals:
yes
Details on study design:
-D0: weighting of the animals. Topical application under porous gauze dressing of the test product for the treated group and of the vehicle (distilled water) for the control group.
- D1: removing of the gauze dressing and rinsing of the treated areas
- D2, D7 and D14: observation of the animals and weighing
- D14: the animals were anaesthetised and autopsy was performed on the organs likely to be modified in cases of acute toxicity.

- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight,organ weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occured 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.
Other findings:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

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 substance 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 substance needs not be classified. No symbol and risk phrase are required.
Executive summary:

The test substance 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 substance 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 substance needs not be classified. No symbol and risk phrase are required.