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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2008/06/03 to 2008/06/17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No deviation occured in this study. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 and was executed in compliance with the Good Laboratory principles.

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)
Remarks:
2007
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch: T73615
Form: pearls
Colour: beige
Storage: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals:
- Sprague Dawley rats originated from Elevage JANVIER (53940 Le Genest St Isle-France)
- Acclimatation period: at least five days
- Weight and old at the begenning of the study: between 219 and 246g (males and between 195 and 215 (females) and were 7-8 weeks old

Housing:
- During the treatment, the animals were kept in individual cage, at D3, the animals were put into their cage by 2 or 3.
- Each cage contains sawdust bedding which was changed at least 2 times a week.
- Environmental conditions:
T° between 19 and 23°C
relative humidity between 41 and 69%
lighting time: 12 hours daily
rate of air exchange: at least ten changes per hour

Food and drinking:
- Drinking water 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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
paraffin oil
Details on dermal exposure:
Animal from group 2 (treated) received by topical application, under porous gauze dressing, an effective dose of 2000mg/kg body weight of LCE 08083, previously heated at 50°C, diluted in liquid paraffin and administrated under a volume of 10mL/kg body weight, during 24 hours. After a 24 hours exposure period, the gauze dressings were removed.
Animals from group 1 (control) received in the same experimental conditions the vehicle (liquid paraffin) under a volume of 2.32 mL/kg body weight.
Duration of exposure:
24 hours
Doses:
2000mg/ kg body weight
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Daily examination:
Systematic examination were carried out to identify any behavioural or toxic effects on the major physiological functions 5 days after administration of the test solution.
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet.
These observations were compared to control data.
Observations and a mortality report were then carried out every day for 14 days.

Periodical examinations:
the animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
Weight changes were calculated and recorded.

Examination at the end of the test:
On D14, macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Thoses presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
It was noted a slight erythema, on the treated area, 24 hours after the test item administration in all treated animals. The treated areas have recovered a normal aspect between D3 (male) and D6 (female).
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not revealed treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD 50 >2000mg/kg body weight 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 and regulation 1272/2008, the test substance needs not be classified. No symbol and risk phrase are required.
Executive summary:

The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3 of the directive n°92/69/EEC.

No mortality occured during the study.

No systemic clinical signs related to the administration of the test item were observed.

it was noted a slight arythema, on the treated area, 24 hours after the test item administration in all treated animals. The treated areas have recovered a normal aspect 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 oh the test item is higher than 2000mg/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, and regulation 1272/2008 the test item need not to be classified. No symbol and risk phrase are required.