L 165

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Leuchtstoffmuster L 165
- 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 or test system and environmental conditions:

- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, 33178 Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 202-222 g (mean weight: 210.1 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:

- One day 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: 404-444 mg/rat (moistened with water)
- 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:

other: No clinical signs of toxicity occurred 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 with the substance, performed in accordance with OECD 402 (1987) and according to GLP principles, a LD50 of >2000 mg/kg bw was determined.

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. 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. In addition, as no erythema or oedema was observed during the observation period, this study does not indicate skin irritation potential.