p-menth-1-en-4-ol

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

no record of the body weight/-gain

GLP compliance:

no

Remarks:

pre GLP-Study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-menth-1-en-4-ol

EC Number:

209-235-5

EC Name:

p-menth-1-en-4-ol

Cas Number:

562-74-3

Molecular formula:

C10H18O

IUPAC Name:

4-methyl-1-(propan-2-yl)cyclohex-3-en-1-ol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Sample markings 76-363, 4-TERPINENOL

Test animals

Species:

rabbit

Administration / exposure

Doses:

1.25, 2.5, and 5.0 g/kg

No. of animals per sex per dose:

4 per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once a day
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 500 - < 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: mortality was observed

Mortality:

In the 5.0 g/kg dose group, 3 animals died within day 1. One more animal died on day 2

Clinical signs:

other: Ataxia and negative righting reflex in 1/each at 5.0 g/kg.

Other findings:

Skin Irritation:
- Redness: 1.25 g/kg: Moderate-2, severe-2
2.5 g/kg - Moderate - l, severe - 3
5.0 g/kg - severe - l
- Edema - moderate in all

Any other information on results incl. tables

Necropsy observations

Dose g/kg	1.25	2.5	5.0
Reddish urine			1
Liver mottled			3
Area of exposure edematous			3
Urine very dark			1
Light eschar formation in exposure area	2	2	1
Areas of lung dark			2
Portions of intestinal wall white			1
Yellow exudate - nose			1
Areas of stomach yellow			1
Heavy eschar formation in area of exposure		1

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions chosen, the test substance revealed a LD50 of greater than 2.5 g/kg.

Executive summary:

A dermal toxicity test in rabbits pre-GLP was conducted. The test was equivalent or similar to the OECD guideline 402. Four animals per dose group were treated with 1.25, 2.5, and 5.0 g/kg of the test substance. Three animals and one animal of the highest test group died on the first day of observation and on the second day of observation, respectively. No deaths occurred at the lower dose groups. Systemic effects were observed to be ataxis and negative righting reflex in each animal at 5.0 g/kg. Skin irritation, from moderate to severe, was observed in all animals. The LD50 was reported to be greater than 2.5 g/kg.