4-(cyclohex-1-en-1-yl)-3-methylbutan-1-ol

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:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(cyclohex-1-en-1-yl)-3-methylbutan-1-ol

EC Number:

806-826-5

Cas Number:

1359994-45-8

Molecular formula:

C11H20O

IUPAC Name:

4-(cyclohex-1-en-1-yl)-3-methylbutan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

- Test substance storage In refrigerator (2-8°C) in the dark
- Description: Clear colourless liquid
- Expiry date: 19 March 2015

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 141-182 g
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
- 2000 mg/kg (2.16 mL/kg) body weight
- 300 mg/kg (0.324 mL/kg) body weight
- Dose volume calculated as dose level (g/kg) / specific gravity

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

- 2000 mg/kg: 3
- 300 mg/kg: 6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15 and at death (if found dead or sacrificed after Day 1); Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

test mat.

Mortality:

At 2000 mg/kg, one animal was found dead and one animal was sacrificed for humane reasons on Day 2.
At 300 mg/kg, no mortality occurred.

Clinical signs:

other: At 2000 mg/kg, lethargy, hunched posture, uncoordinated movements and piloerection were noted for all animals on Days 1 and/or 2. Additionally, the animal sacrificed for humane reasons also showed lateral recumbency, laboured respiration and hypothermia o

Gross pathology:

At 2000 mg/kg, abnormalities of the kidneys (papilla: discolouration, reddish and/or pelvic dilation) and/or urinary bladder (reddish contents) were found in the animals that died (or sacrificed for humane reasons) during the study. Macroscopic examination of the surviving animal at termination did not reveal any abnormalities.
At 300 mg/kg, macroscopic examination at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria