Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1955
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is performed with a 35,8% active ingredient formulation, and not under GLP compliance. However, the study is conducted according to state of the art methods at that period. Therefore the study is considered to be adequate, reliable and relevant.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1955
Report Date:
1955

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Observation period of 7 days instead of 14 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: Not provided
- Fasting period before study: Not provided
- Housing: Individually
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS
Not provided


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: abdomen
- % coverage: Not provided
- Type of wrap if used: The material was applied to the closely clipped abdominal skin under rubber damming. The trunks of the animals were wrapped securely with a gauze and adhesive tape binder.

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

TEST MATERIAL
- Concentration (if solution): 35.8%
- Constant volume or concentration used: no


Duration of exposure:
24 hours
Doses:
1.00 mL/kg, 2.15 mL/kg, 4.64 mL/kg and 10 mL/kg
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Not provided
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3.5 other: g/kg bw
Based on:
act. ingr.
Remarks:
35%
Mortality:
There were no mortalities at any dosage level tested.
Clinical signs:
Throughout the observation period the animals exhibited normal behavior and appearance. A single dermal application produced a mild degree of dermal irritation.
Body weight:
At the time of sacrifice, the majority of the animals exhibited an increase over their initial body weights.
Gross pathology:
At gross autopsy the organs of all animals appeared to be within normal limits.
Other findings:
Not provided

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of undiluted test item for albino rabbits is > 10 mL/kg bw, corresponding to > 3500 mg act.ingr./kg bw.
Executive summary:

Groups of four albino rabbits were used to study the dermal toxicity and irritative properties of the test item containing 35.8% act. ingr. following a single application of the undiluted material at dosage levels of 1.00, 2.15, 4.64, or 10 mL/kg of body weight. The material was applied to the closely clipped abdominal skin under rubber damming. The trunks of the animals were wrapped securely with a gauze and adhesive tape binder. After an exposure of 24 hours the binders were removed and the abdomens were sponged with water in order to remove any unabsorbed material. The animals were observed for gross signs of dermal irritation and systemic toxicity for a period of seven days, after which they were sacrificed and gross autopsies performed. There were no mortalities at any dosage level tested. A single dermal application produced a mild degree of dermal irritation. The acute dermal LD50 of undiluted test item for albino rabbits is > 10 mL/kg bw, corresponding to > 3500 mg act.ingr./kg bw.