Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral in mice: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel. 2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
Specific details on test material used for the study:
- Sample marking: 74-56
- Name of test material: carrot seed oil
Species:
mouse
Strain:
not specified
Sex:
not specified
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
Preliminary study:
Not applicable
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

None

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Adequate for hazard assessment

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: via oral route

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.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

- not classified according to the Regulation (EC) No. 1272/2008 and GHS.

Acute toxicity via Dermal route:This information is not available

Acute toxicity via Inhalation:This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal): This information is not available

Specific target organ toxicity: single exposure (Inhalation): This information is not available.

Based on its composition (> 10% of aspiration toxicants or hydrocarbons), the registered substance is classified for aspiration hazard category 1, H304 according to CLP Regulation and GHS.