(1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019-02-18 to 2019-03-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

(1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol

Cas Number:

22972-51-6

Molecular formula:

C10H16O

IUPAC Name:

(1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol

Test material form:

liquid

Details on test material:

Test item: (1S,4R)-1-Methyl-4-(prop-1-en-2-yl)cyclohex-2-enol
CAS number: 22972-51-6
Physical state: Liquid
Storage: Room temperature

Specific details on test material used for the study:

Test item: (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol (PMDOL)
CAS number: 22972-51-6
Physical state: Liquid
Storage: room temperature
Batch No. 118000-182001

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BioLASCO Taiwan CO., Ltd.
- Females (nulliparous and non-pregnant)
- Age at study initiation: 8 weeks
- Housing: single housing
- Access to feed: ad libitum
- Water access: ad libitum
- Acclimation period: 8 days before starting the test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ° C ± 3 °C
- Humidity (%): 50 % ± 20%
- Lighting: 12 hours (06:00 on, 18:00 off)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

Preparation:
- Concentration in vehicle: 60 and 400 mg/mL
- Dosing volume: 5 mL/kg bw

Method of administration: after an overnight fast, each animal received a single oral dose of the test substance.

Doses:

300 and 2000mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
-Body weighing: Individual body weights on the first day prior to administration, weekly thereafter
-- Clinical observations: all animals were observed individually twice after administration and subsequently once daily for up to fourteen days
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, gross finding

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 animal death found in the 300 mg/kg bw test groups or in the second 2000 mg/kg bw test group.
In the first 2000 mg/kg bw test group, one of three animals was found dead on study day 1.

Clinical signs:

other: No clinical signs were observed in the 300 mg/kg bw test groups. Abnormal clinical signs of hunchbak or loss of activity were observed in all animals of the 2000 mg/kg bw test groups at 0.5 and 4 hours (day 0) after administration. One animal in the firs

Gross pathology:

There were no significant gross lesions in survived animal sacrificed at the end of the observation period (2000 mg/kg bw: 5 females; 300 mg/kg bw: 6 females).
No gross pathological changes were observed in the single animal died in the first 2000 mg/kg bw test group.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The oral median lethal dose (LD50) of the substance is ranked within 2000-5000mg/kg in rats and is not considered to be classified as acute toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.