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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 August 1998 to 27 August 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conducted to recent EU test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): T-9601
- Physical state: Powder
- Analytical purity: 94.7
- Lot/batch No.: HI-295
- Expiration date of the lot/batch: May 2001
- Stability under test conditions: is guaranteed for 4 hours
- Storage condition of test material: darkness at approximately 5 C in a refrigerator

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HARLAN WINKLEMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: Males - 271g, Females - 215g
- Housing: Fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate, one animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: seven days

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Sesame Oil (Oleum sesami DAB 10)
Details on dermal exposure:
TEST SITE
- Area of exposure: Approximately 30 cm2
- Type of wrap if used: Foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0ml per -0.5g
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Males - 5
Females - 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations twice daily (morning and afternoon), on weekends and bank holidays only once. Animals weighed weekly.
- Necropsy of survivors performed: yes
Statistics:
Not reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs of toxicity related to dose levels was observed during the study.
Body weight:
Development of body weight was sporadically disturbed in male and female animals.
Gross pathology:
Effects on organs: No macroscopic visable changes were observed.
Other findings:
The skin surface of the animals was large discoloured orange up to day six of the study

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in the study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 2000 mg/kg body weight.
Executive summary:

Study data conducted to EEC-Guideline B.3 of the Directive 92/68/EEC and OECD Guidleines for Testing of Chemicals 402 in compliance with GLP.

The median lethal dose value (LD50) of the substance for the male & female rat is greater than 2000 mg/kg body weight.