Melaleuca alternifolia, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Non-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Melaleuca alternifolia, ext.

EC Number:

285-377-1

EC Name:

Melaleuca alternifolia, ext.

Cas Number:

85085-48-9

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).

IUPAC Name:

Essential oil of melaleuca alternifolia

Test material form:

liquid

Specific details on test material used for the study:

Batch No. of test material: 88/375
Purity: 100%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Test animals: 5 male and 5 female albino rabbits.
- Weight at study initiation: 2.44 to 3.03 kg
- Age at study initiation: Not reported.
- Source: Not specified.
- Housing conditions: Not reported.
- Environmental conditions: Not reported.

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Area of exposure: Approximately 175 cm².

Duration of exposure:

Duration of exposure: 24 hours.

Doses:

A single dose of 2000 mg/kg.

No. of animals per sex per dose:

5 males and 5 females.

Control animals:

no

Details on study design:

The animals were observed during the 24 hour exposure period and daily for 14 days after the exposure period. Observations were made for any signs of toxicity and abnormal behaviour. The animals were weighed on days 0, 7 and 14 (see Table 1 in 'Any other information on materials and methods').

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: One in ten animals exhibited slight diarrhoea on Day 3. There were no other signs of toxicity or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A group of 5 male and 5 female rabbits was treated with Tea Tree Oil Batch 88/375 at a rate of 2000 mg/kg dermally. Slight diarrhoea occurred in one animal. The acute dermal LD50 was determined to be > 2000 mg/kg.

Executive summary:

A study was conducted in accordance with OECD Guideline 402 to determine the acute dermal toxicity of Tea Tree Oil in the rabbit. A group of 5 male and 5 female rabbits was treated with Tea Tree Oil Batch 88/375 at a rate of 2000 mg/kg dermally.  Slight diarrhoea occurred in one animal. There were no mortalities and the acute dermal LD50 was determined to be > 2000 mg/kg. Tea Tree Oil does not meet the criteria for classification under GHS.