Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-guideline and pre-GLP study. Only basic data given. However, the result was non-toxic at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
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:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
A single dermal dose of test material was applied to the skin of 10 rabbits
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
none

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
none

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no data
Statistics:
none

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occurred during the study
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
Skin irritation:
- Slight redness: 5/10
- Moderate redness: 3/10
- Slight edema: 1/10
- Moderate edema: 1/10

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

In a limit acute dermal toxicity study, 10 rabbits were exposed to the test material at dose of 5000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions for 14 days.

 

No mortality occurred during the study.

Skin irritation was observed in the animals: 5/10 had slight redness, 3/10 moderate redness, 1/10 slight erythema, 1/10 moderate erythema.

 

Dermal LD50> 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

Even if only few details were available on method used in this study, the result was "non-toxic at 5000 mg/kg bw" which is 2.5 times more than is needed for the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover the acute dermal toxicity endpoint.