Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.