Lavender, Lavandula hybrida, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no data about purity and no certificate of analysis of the test substance; no data on strain/sex of animals dosed; environmental conditions not reported; 7 days observation period

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data about purity and no certificate of analysis of the test substance; no data on strain/sex of animals dosed; environmental conditions not reported; 7 days observation period

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 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

Constituent 2

Reference substance name:

Linalyl acetate

EC Number:

204-116-4

EC Name:

Linalyl acetate

Cas Number:

115-95-7

Molecular formula:

C12H20O2

IUPAC Name:

3,7-dimethylocta-1,6-dien-3-yl acetate

Test material form:

liquid

Specific details on test material used for the study:

None

Test animals

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Fasting period before study: 4 hours
- Diet fed after treatment: Commercial stock diet

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

None

Doses:

5 mL/kg bw

No. of animals per sex per dose:

6 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

No mortality was noted during the 7 day observation period.

Clinical signs:

other: Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours.

Gross pathology:

Animals presented a normal apperance at autopsy, apart from one male mouse that appeared immature.

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, the oral LD50 of the test substance is >5 mL/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Executive summary:

In an acute oral toxicity study, a single oral dose of 5 mL/kg bw of the undiluted test substance was given to 6 mice. Animals were then observed for mortality and clinical signs of toxicity for 7 days.

 

No mortality was noted during the 7 day observation period. Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours. Animals gained weight and presented a normal apperance at autopsy, apart from one male mouse that lost 3 g and appeated immature at autopsy.

 

Mice Oral LD50 > 5 mL/kg bw.

 

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