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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Mice were given a single oral dose of test substance up to 5 mL/kg bw and then observed for 14 days.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Concrete obtained from lichen of Pseudevernia furfuracea (syn evernia furfuracea)(Parmeliaceae) by extraction with a mixture of polar and apolar solvents
IUPAC Name:
Concrete obtained from lichen of Pseudevernia furfuracea (syn evernia furfuracea)(Parmeliaceae) by extraction with a mixture of polar and apolar solvents
Specific details on test material used for the study:
- Name of test material: TRNO-25

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
4, 4.5 and 5 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs at least daily for 14 days

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4.33 mL/kg bw
Based on:
test mat.
95% CL:
>= 4.01 - <= 4.68
Mortality:
3/10 at 4 mL/kg bw
5/10 at 4.5 mL/kg bw
9/10 at 5 mL/kg bw
Clinical signs:
No data
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:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, oral LD50 of test substance is 4.85 g/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and classified category 5 (H303) according to GHS.
Executive summary:

In an acute oral toxicity study, 10 rats/dose were given a single oral dose of test item at 4, 4.5 and 5 mL/kg bw. Animals were then observed for mortality and clinical signs at least daily for 14 days.

3/10, 5/10 and 9/10 deads were observed at 4 mL/kg bw, 4.5 mL/kg bw and 5 mL/kg bw, respectively. The calculated LD50 was 4.33 mL/kg bw with 90% confidence limits of 4.01-4.68 mL/kg bw, corresponding to 4.85 g/kg bw and 90% confidence limits of 4.52-5.28 g/kg bw with a density of 1.1278.

 

Under the test conditions, oral LD50 of test substance is 4.85 g/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and classified category 5 (H303) according to GHS.