Registration Dossier

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

Constituent 1
Chemical structure
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:
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 first 2000 mg/kg bw test group was found dead on day 1. The abnormal clinical signs of survived animals were recovered on day 2.
Body weight:
All survived animals showed expected gains in body weight over the study period.
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.