p-mentha-1,4-diene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

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

Specific details on test material used for the study:

Test Item: Gamma Terpinene
Lot Number: 161215
Purity: 98 %
CAS No 99-85-4
EINECS-No 02-794-6
Appearance: Clear, liquid
Composition: Gamma Terpinene
Production Date: 15 December 2016
Expiry Date: 14 December 2018
Storage: Room temperature (20 ± 5°C); keep away of light

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The animals were observed individually immediately after the administration 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.

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body
weight. Available information indicated that the test item is likely to be non-toxic with regard to
acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose.

No. of animals per sex per dose:

6

Details on study design:

The purpose of the study was to evaluate the potential toxic effect of the test item Gamma
Terpinene after single oral administration in rats. The procedure according to OECD Guideline 423
Acute Toxic Class Method was used. The ATC method is not designed to determine a point
estimate of LD50. It provides a range estimate of LD50 defined by cut-off values of the applied
classification system and not as a calculated lower and upper level. The method provides
information on hazardous properties and allows the test item to be ranked and classified according
to the Globally Harmonised System (GHS) of Classification and Labelling of Chemicals.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study

Clinical signs:

other: No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The test item Gamma Terpinene administered to 6 females at dose of 2000 mg/kg body weight did
not cause death. No signs of toxicity were observed during the first 4 hours in females or the 14-day
observation period thereafter. No body weight losses were observed between one and two weeks
after administration of the test item. During necropsy, no macroscopic findings were observed.

The LD50 of the test item Gamma Terpinene is greater than 2000 mg/kg body weight after single
oral administration to Wistar rats.