Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 23, 2006 - November 14, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed in accordance with OECD 402 (1987) and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
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:
- Name of test material (as cited in study report): Leuchtstoffmuster L 130
- Appearance: white, microcrystalline solid
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, 33178 Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 201-220 g (mean weight: 208.8 g)
- Body weight variation: less than 20% of the mean weight
- Housing: individually in Makrolon cages
- Diet: SDS RM1 Nagerfutter, Withham Essex, England. Twice 8 g daily.
- Water: Free access to tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: moistened with water
Details on dermal exposure:
- 24 hours before exposure the dorsal area of the trunk was shaved in an area of approximately 10% of the body surface
- The dosage was applied onto gauze and moistened with water
- The gauze was applied onto the shaved area and was held in place with an occlusive bandage
- The bandage was fixed with 1.25 cm broad stripes of Adhesive tape.
- Frequency: Single dosage
- At the end of the exposure period residual test item was removed by gently washing with water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw

No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Dose volume: 402-440 mg/rat
- Duration of observation period following administration (on day 1): 14 days
- Frequency of observations and weighing:
Mortality/Viability: daily
Body weights: daily
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities and no clinical signs of toxicity occurred
Mortality:
No mortalities occurred.
Clinical signs:
No clinical signs of toxicity occurred in any of the animals.
Body weight:
No abnormalities were observed in any of the animals.
Gross pathology:
Macroscopic examination of the animals did not reveal any abnormalities.
Other findings:
No erythema or oedema was observed during the observation period. Therefore this study does not indicate skin irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study with rats, performed in accordance with OECD 402 (1987) and according to GLP principles, a LD50 of >2000 mg/kg bw was determined for the substance.
Executive summary:

The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987) and according to GLP principles. The substance was administered to five Sprague-Dawley rats of each sex by a single dermal application of 2000 mg/kg bw for 24 hours. No mortality and no clinical signs of toxicity occurred in any of the animals. Body weight determinations and macroscopic examination of the animals did not reveal any abnormalities. The dermal LD50 value of the substance in Sprague-Dawley rats was established to be >2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity by the dermal route.