p-menth-1-en-4-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

10 animals/group, no record of bodyweight/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:

rat

Administration / exposure

Route of administration:

oral: unspecified

Doses:

0.6, 1.22, 2.47, and 5.0 g/kg

No. of animals per sex per dose:

10 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:

1 300 mg/kg bw

Based on:

test mat.

Mortality:

In the 0.6 g/kg dose group one animal died. In the 1.22 g/kg dose group, 4 animals died. In the 2.47 g/kg dose group, 9 animals died and in the 5.0 g/kg dose group, all animals died. In all dose groups, the animals died on day 1 after administration of the test substance.

Clinical signs:

other: Symptomatology Rats: 0.6 g/kg - ataxia, lethargy, tremors, chromorhinorrhea, chromodacryorrhea 1.22 g/kg - lethargy, ptosis, pile-erection chromorhinorrhea 2.47 g/kg - salivation, chromorhinorrhea, ataxia 5.0 g/kg - coma and death

Any other information on results incl. tables

Necroscopy Observations

Dose g/kg	0.6	1.22	2.47	5.0
Lungs dark	1	4	9	9
Liver dark	1	4	8	7
Areas of redness in intestines	1	4	6	6
Kidneys dark	1	2	2	3
Dried blood around eyes			3
Yellow exudate - nose and mouth			3
Portions of intestines yellow			3
Portions of stomach red			3
Bloody urine in bladder			2
Red exudate - mouth			2
Kidneys mottled		3	1

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions chosen and the results obtained, the test substance is considered to be classified as acute toxic category 4 (H302: harmful if swallowed). The LD50 was reported to be 1.3 g/kg.

Executive summary:

An acute toxicity test via the oral route was performed pre-GLP. The test was equivalent or similar to the OECD guideline 401. Ten rats per dose group were treated with 0.6, 1.22, 2.47, and 5.0 g/kg of the test substance of which died at the first observation day 1/10, 4/10, 9/10, and 10/10, respectively. The LD50 was reported to be 1.3 g/kg. Necropsy observations revealed dark lungs, dark liver, dark kidneys, and areas of redness in intestines, among others.