p-cymene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: method of Litchfield & Wilcoxon (1949)

Principles of method if other than guideline:

- Principle of test: Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for
approximately 18 hr prior to treatment. Animals had access to water at all times, and food was replaced in cages as soon as animals received their respective doses.
- Short description of test conditions: Undiluted p-Cymene in diffrent concetrations was administrated to all rats by intubation.
- Parameters analysed / observed: ll animals were maintained under close observation for recording toxic signs artd time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observatiort period was 2 weeks.

GLP compliance:

no

Test type:

other: Acute oral toxicity

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-cymene

EC Number:

202-796-7

EC Name:

p-cymene

Cas Number:

99-87-6

Molecular formula:

C10H14

IUPAC Name:

1-isopropyl-4-methylbenzene

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rats:
Osborne-Mendel
- Females and males
- Diet ad libitum
- Water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Undluted p-Cymene was administrated to male and female rats by oral incubation.

Doses:

Undluted p-Cymene was administrated to rats

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: not specified
- All animals were maintained under close observation for recording toxic signs artd time of death. Such observation was continued until animals appeared normal and showed weight gain.

Statistics:

LD50 was computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 750 mg/kg bw

Based on:

test mat.

95% CL:

ca. 3 720 - ca. 6 060

Mortality:

Indicated time of death: 4hr - 2 weeks

Clinical signs:

other: Rats showed depression shortly following dosing and also coma, bloody lacrimation, diarrhea with irritable, scrawny appearance during the observation period

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU CLP

Conclusions:

Based on the results, The LD50 was calculated to be 4750 mg/kg bw (95% confidence limits: 3720-6060).

Executive summary:

In the study of Jenner et al. (1964), groups of 10 male and 10 female Osborne-Mendel rats were orally administered undulitued p-cymene at various doses (not specified) to calculate an oral LD50. Rats were monitored for up to 2 weeks. The death time after exposure to p-cymene was indicated, as follows: from 4 hr till 2 weeks.

Rats showed depression shortly following dosing. Other clinical signs included: coma, bloody lacrimation, diarrhea with irritable, scrawny appearance during the observation period.

The LD50 was calculated using the method of Litchfield & Wilcoxon (1949). The LD50 was determined to be 4750 mg/kg bw (95% confidence limits: 3720-6060). with a slope function of 1.7

Based on the results, it is concluded that p-Cymene should not be classified as acute oral toxic under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.