Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Performed pre-GLP, method is described briefly (refer to the "principles of method" field)
Principles of method if other than guideline:
- Short description of test conditions: Dermal application of Nourypol 200 at dose levels of 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- Parameters analysed / observed: growth, food and water intake and haematology, as well ass Gross examination at autopsy
GLP compliance:
no
Remarks:
Prior to GLP adoption
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Not Specified

Test animals

Species:
rabbit
Strain:
other: Albino
Remarks:
No further specification regarding the strain
Sex:
male/female
Details on test animals and environmental conditions:
Not specfied

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight

Duration of exposure:
Not specified
Doses:
0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
No. of animals per sex per dose:
Not specified
Control animals:
yes
Remarks:
The 0.0 ml/kg body weight (control) dosed group was used as control
Details on study design:
- Frequency of observations and weighing: Haeatological data was obtained 2 weeks after a single dermal appliaction. other observation frequencies are not specified.
- Necropsy of survivors performed: yes
- Other examinations performed: growth, food and water intake, haematology, gross examination
Statistics:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 mL/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
slight skin effects at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg.
Body weight:
Test groups were comparable with the data obtained for control rabbits
Gross pathology:
Gross examination at autopsy did not reveal any clearly treatment-related changes

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Based on CLP criteria
Conclusions:
Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

An acute dermal toxicity study with "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was performed in a study similar to OECD TG 402, pre-GLP, scored Klimisch 2.

"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested at 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight in albino rabbits. Duration of observation period following administration: 14 days, growth, food and water intake, haematology and gross pathology were examined. No mortality occurred, slight skin effects were seen at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg. Gross examination at autopsy did not reveal any clearly treatment-related changes. Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute toxicity.