Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. 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:
10 rats were treated with a single dose of 5000 mg/kg bw and observed for a 14-day period
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:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
none

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
none
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 levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
one animal died on day 1
Clinical signs:
Rats were slightly lethargic
Body weight:
no data
Gross pathology:
no data
Other findings:
none

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:
Oral LD50 > 5000 mg/kg bw
Executive summary:

In a limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.

 

One animal died on Observation Day 1. No other mortality occurred during the study. Rats were slightly lethargic.

 

Oral 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 the Directive 67/548/EEC.

Even if only few details were available on method used in this study, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw which is 2.5 times more than is needed for the OECD 401. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover the acute dermal toxicity endpoint.