Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-11-01 to 1991-01-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
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:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
Distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: 25 cm2 (5x5 cm) for males and 18 cm2 (3.5x3.5 cm) for females
- % coverage: ca 10%
- Type of wrap if used: The formulation was applied by application on a gauze patch fixed successively to aluminium foil and flexible bandage, with drops of petrolatum.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with tissue moistened with tap-water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight.
- Concentration (if solution): 200 mg/ml
- Constant volume or concentration used: yes, 10 ml/kg body weight.
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Concentration (if solution): distilled water was used
- Lot/batch no. (if required): distilled water was used
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality/Viabity: At periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days.
Weighing: Days 1 (pre-administration), 8 and 15.
Symptoms: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin (treated skin), fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, others see above
Statistics:
No statistics applied.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
No clinical signs of ill health or behavioural changes were seen during the observation period. No signs of skin irritation were observed on the treated area during the study period.
Body weight:
Slight body weight gain was noted over the first week with recovery of body weight gain over the second week of observation.
Gross pathology:
No treatment-related sign of toxicity. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
Other findings:
All animals showed blue staining of the treated skin by the test substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of the substance in rats was established as exceeding 2000 mg/kg body weight. No classification of the test item as to its dermal toxicity properties according to both the old EEC Directive 83/467/ECC and the new CLP regulation EC 1272/2008.