Ocimum basilicum, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Pre-GLP, pre-guideline study which seems to be performed under standardized conditions.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

Information is derived from read across

Justification for type of information:

The read across justification is presented in the acute toxicity endpoint summary and the accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 790 mg/kg bw

95% CL:

> 2 440 - < 3 180

Remarks on result:

other: Slope function 1.3 (95% CI 1.2-1.4)

Interpretation of results:

other: Not acute toxic

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed a LD50 of 2790 mg/kg bw. Based on this result, the test substance is considered to have a relatively low acute toxicity hazard via the oral route. In accordance with the criteria outlined in the UN-GHS legislation, the substance should be classified for acute oral toxicity (Acute Tox. 5 / H303).

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Linalool

EC Number:

201-134-4

EC Name:

Linalool

Cas Number:

78-70-6

Molecular formula:

C10H18O

IUPAC Name:

3,7-Dimethylocta-1,6-dien-3-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adults
- Weight at study initiation: no data
- Fasting period before study: 18 hours
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Not specified

Doses:

Not specified

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week.
- Frequency of observations and weighing: Frequency not known, all animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal or showed weight gain.

Statistics:

LD50's were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 790 mg/kg bw

95% CL:

> 2 440 - < 3 180

Remarks on result:

other: Slope function 1.3 (95% CI 1.2-1.4)

Mortality:

Time of death between 4 and 18 hours after exposure

Clinical signs:

other: Ataxia was observed soon after treatment

Gross pathology:

Not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not acute toxic

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed a LD50 of 2790 mg/kg bw. Based on this result, the test substance is considered to have a relatively low acute toxicity hazard via the oral route. In accordance with the criteria outlined in the UN-GHS legislation, the substance should be classified for acute oral toxicity (Acute Tox. 5 / H303).

Executive summary:

The acute oral toxicity of Linalool to rats was investigated, in a study performed similar to OECD TG 401. Ten Osborne-Mendel rats per concentration were used, the substance was administered orally via gavage, in a fasted state. Clinical signs and mortality were recorded over a 2 week period. The rats showed ataxia soon after treatment and mortality was observed after 4 -18 hrs. The LD50 was determined to be 2790 mg/kg body weight (confidence interval 2440 -3180).