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
Report Date:
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 at 5000 mg/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:
- Sample marking: 74-56
- Name of test material: carrot seed oil

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5 g/kg bw
No. of animals per sex per dose:
No data
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:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
2/10 animals on Day 1
Clinical signs:
Lethargy
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:
GHS criteria not met
Conclusions:
Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in mice therefore it is not classified according to the Regulation (EC) N° 1272-2008 and GHS.
Executive summary:

In an acute oral toxicity study (limit test), 10 mice were given a single oral dose of carrot seed oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs at least daily for 14 days.

Two out of 10 animals died on Day 1. Lethargy was observed. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in mice therefore it is not classified according the Regulation (EC) N° 1272-2008 and GHS.