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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:
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Adopted July 31, 1992
Deviations:
no
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 levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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.