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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:
02 - 16 Nov 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministère de l'Économie, des Finances et de l'Industrie, Secrétariat général du groupe interministériel des produits chimiques, DGCIS, Service de l'industrie, bureau de la chimie, Paris, France
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER, Le Genest Saint Isle, France
- Age at study initiation: 7 weeks (males) and 8 weeks (females)
- Weight at study initiation: 221-238 g (males) and 206-217 g (females)
- Housing: rats were housed individually in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contained dust free wood shavings.
- Diet: pelleted diet M20 (SDS), ad libitum
- Water: tap-water from the public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin of the dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: the test material was held in contact with the skin with a gauze dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated areas were rinsed with liquid paraffin.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Concentration: 21.7% (2 g of test material dissolved in 10 mL of olive oil with a density of 0.92 g/mL)
- Constant volume or concentration used: yes

VEHICLE
- Amount applied: 10 mL/kg bw
- Concentration (if solution): 100%
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animal was weighed on Day 0 (before test substance administration), 2, 7 and 14. Systemic examinations were carried out daily during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, necropsy included macroscopic examination of animals
Statistics:
For body weights, mean values and standard deviations were calculated for all animals.

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 occurred during the study period.
Clinical signs:
Neither cutaneous reactions nor systemic clinical signs were observed up to the end of the 14-day observation period.
Body weight:
Body weight evolution of the animals remained within the normal ranges in males and females during the whole study period.
Gross pathology:
Macroscopic examination did not reveal substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified