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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
- Standard acute method (limit test)
GLP compliance:
no
Remarks:
(pre-GLP)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction
EC Number:
951-779-7
Molecular formula:
Not relevant, UVCB substance
IUPAC Name:
Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction
Test material form:
other: Semi-solid
Details on test material:
- Description: A dark brown, semi-solid mass

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total: 10 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, bservations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
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: No mortality occurred during the study.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No clinical signs were observed.
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats. Therefore, the test substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Tabac absolute at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

No mortality occurred during the study. No clinical signs were observed. In this study, the oral LD50 of Tabac absolute was higher than 5000 mg/kg bw in rats.

Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats. Therefore, the test substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.