Lavender, Lavandula angustifolia, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

Standard acute method (limit test): 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lavender, Lavandula angustifolia, ext.

EC Number:

289-995-2

EC Name:

Lavender, Lavandula angustifolia, ext.

Cas Number:

90063-37-9

Molecular formula:

not relevant for a UVCB substance

IUPAC Name:

Essential oil of Lavandula angustifolia Mill. (Lamiaceae) obtained from flowering tops by steam distillation

Test material form:

liquid

Specific details on test material used for the study:

None

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

None

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

None

Duration of exposure:

After single application of the test subsance, all animals were observed for 14 days.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 rabbits

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: Mortality, clinical signs and dermal reactions.
- Necropsy of survivors performed: No

Statistics:

None

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.

Remarks on result:

other: indication of slight to moderate irritation

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs of toxicity occurred during the study.

Gross pathology:

Not applicable

Other findings:

- Dermal reactions: Slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.

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 dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Executive summary:

In an acute dermal toxicity study (limit test), 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.

No deaths and no clinical signs of toxicity occurred during the observation period. Dermal reactions noted were slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.

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