p-mentha-1,4-diene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-mentha-1,4-diene

EC Number:

202-794-6

EC Name:

p-mentha-1,4-diene

Cas Number:

99-85-4

Molecular formula:

C10H16

IUPAC Name:

p-mentha-1,4-diene

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Details on dermal exposure:

Animals were observed individually immediately after the application of the test item and then 0.5,
1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days.

Duration of exposure:

14-day

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

The purpose of the study was to evaluate the potential toxic effect of the test item Gamma
Terpinene when applied as a single dermal dose to Wistar rats. The procedure according to OECD
Guideline 402 Acute Dermal Toxicity and OECD Proposal for a New Draft Guideline 434: Acute
Dermal Toxicity-Fixed Dose Procedure was used.
A limit dose of 2000 mg/kg body weight was used as starting dose. One female was dosed. Test
item-related mortality was not observed during 24 hours. A total of five female rats were dosed with
a limit dose of 2000 mg/kg body weight. An additional group of 5 males was tested at the same
dose.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed during the study.

Clinical signs:

other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.

Gross pathology:

All animals (5 females and 5 males) were necropsied. During necropsy, no macroscopic changes
were noticed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on OECD Guideline 402 and OECD Guideline Draft 434 it can be concluded, that for the test
item Gamma Terpinene according to the Globally Harmonised System and Category Labelling of
Chemicals can be classified in Category 5/Unclassified with LD50 value greater than 2000 mg/kg
body weight after single dermal application to Wistar rats.

Executive summary:

The test item Gamma Terpinene applied to 5♀ and 5♂ at a limit dose of 2000 mg/kg body weight

did not cause death. All females and males survived the limit dose of 2000 mg/kg body weight. No

body weight losses in males and mildly increase and decrease or stagnation in females were

observed between one and two weeks after application of the test item. No signs of toxicity were

observed at the dosage of 2000 mg/kg body weight during the first 4 hours in females or 14-day

observation period. No dermal changes were observed. During necropsy no macroscopic findings

were noticed.