[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jun - Jul 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Adopted July 31, 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

Adopted Feb 24, 1987

Deviations:

no

GLP compliance:

yes

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 or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation:
males: 259 +/- 5.6 g
females: 223 +/- 9.3 g
- Fasting period before study:no, not required
- Housing: in transparent macrolon cages (type III) on soft wood granulate in air-conditioned room, 1 animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 25. June To: 9. July 2003

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: moistened with tylose

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x8 cm
- % coverage: 100
- Type of wrap if used: ealstic plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (0.5 g test item moistend with 0.5 mL tylose)
- For solids, paste formed: yes, moistned with 0.5 mL tylose

VEHICLE
- Amount(s) applied (volume or weight with unit): tylose

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, twice daily

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study

Clinical signs:

No symptoms were observed.
The male animals showed reddish discolored skin one day after treatment, when the bandage was removed. Females showed reddish discolored skin on day 1 and 2 after treament.

Body weight:

Development of body weight was not impaired. One of five females showed a slight loss of body weight in the first study week, but body weight gain was nomalised in the second week.

Gross pathology:

no macroscopically visible changes reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the reesults obtained in this study the LD50 (dermal) of the test item for male and female rats is greater than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity testing of the test item yielded a LD50 > 2000 mg/kg bw in both male and femal animals. After administration of 2000 mg/kg w neither deaths nor symptoms occurred. The male animals showed reddish discolored akin one day after treatment when the bandage was removed. Females showed reddish discolored skin on day 1 and 2 after treatment. Development of body weight was not impaired in male animals. One of five females showed a slight body weigth loss in the first study week, but body weight gain normalised in the second study week. No animal showed macroscopically visible changes.