Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973-01-23 to 1973-09-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Test type:
standard acute method

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: clinical signs daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
n.a.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no data
Clinical signs:
no effects
Body weight:
no data
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the results, the acute dermal LD50 in rats is greater than 5000 µL/kg body weight.
Executive summary:

In an acute dermal toxicity study, rats were dermally exposed to the undiluted test item and were observed afterwards for 7 days. No clinical signs and no gross pathological effects were observed. Based on the results from this study, the dermal LD50 in rats can be considered to be greater than 5000 µL/kg bw. Due to poor documentation of the method and results, the study cannot be used for classification according to CLP criteria and is used as supporting information only.