Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 402 with deviations: purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
purity of test item not reported; duration of exposure, source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
2500 and 5000 mg/kg bw
No. of animals per sex per dose:
2 animals at 2500 mg/kg and 8 at 5000 mg/kg
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 3 days
- Necropsy of survivors performed: Yes; gross necropsy was performed on all animals at the termination of the study.
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: One rabbit died on Day 2 and one on day 3, out of 8 animals
Mortality:
One rabbit died on Day 2 and one on Day 3
Clinical signs:
Slight redness at 5000 mg/kg in one rat and moderate redness and edema in others, ataxia, ptosis and piloerection were observed.
Body weight:
No data
Gross pathology:
Liver mottled, lungs dark and area of exposure very red and edematous in one animal.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.
Executive summary:

In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.

Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw. The dermal LD50 of the test item was considered to be higher than 5000 mg/kg bw in rabbits.

The acute dermal LD50 of Nopol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.