3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Feb - Mar 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols with no minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. Assigned reliability score of 2 on the basis that the test substance is being used for read-across.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

(High dose group of 1000 mg/kg)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol

EC Number:

267-140-4

EC Name:

3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol

Cas Number:

67801-20-1

IUPAC Name:

3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-2-ol

Details on test material:

IUPAC name : 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)-4-penten-2-ol
Molecular formulae : C14H24O
CAS number : 67801-20-1
EINECS number : 267-140-4
Description : Pale yellow liquid
Batch number : VE00071661
Purity : 96% (sum of isomers)
Expiry date : 10 June 2011
Storage conditions : Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK
- Age at study initiation: approximately six to eight weeks old
- Weight at study initiation: males weighed 178 to 211g, the females weighed 152 to 173g
- Fasting period before study:
- Housing: groups of three by sex in solid floor polypropylene cages with stainless steel mesh lids and softwood flake bedding (Datesand Ltd, Cheshire, UK).
- Diet (e.g. ad libitum): Pelleted diet (Rodent 2014C Teklad Global Certified Diet, Harlan Laboratories U.K. Ltd., Oxon, UK ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libitum
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2ºC
- Humidity (%): 55 ± 15%
- Air changes (per hr): at least fifteen air changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness

Doses:

100, 500 and 1000 mg/kg/day

No. of animals per sex per dose:

3 per sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: All animals were examined for overt signs of toxicity, ill health or behavioural change immediately before dosing, up to thirty minutes after dosing and one hour after dosing. Additional observations were also made five hours following dosing whenever possible. Observations taken for 14 days.
- Necropsy of survivors performed: yes. On completion of the dosing period, all animals were killed by intravenous overdose of a suitable barbiturate agent followed by exsanguination and subjected to an internal and external macroscopic examination. No tissues were retained.
- Other examinations performed: clinical signs, body weight.

Statistics:

Data were processed to give individual animal/group mean values, standard deviations and incidence of findings where appropriate.

Results and discussion

Preliminary study:

n/a

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no effects observed

Mortality:

There were no unscheduled deaths during the study.

Clinical signs:

other: Incidents of increased salivation were evident throughout the treatment period in animals of either sex treated with 1000 and 500 mg/kg/day. Observations of this nature are commonly observed following oral administration of an unpalatable test material fo

Gross pathology:

There were no treatment-related macroscopic abnormalities detected at necropsy.

Other findings:

n/a

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The oral administration of Ebanol to rats for a period of seven consecutive days at dose levels of 100, 500 and 1000 mg/kg/day produced no toxicologically significant effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) and a suitable high dose level for use on future toxicity studies was, therefore, considered to be 1000 mg/kg/day.

Executive summary:

The oral administration of Ebanol to rats for a period of seven consecutive days at dose levels of 100, 500 and 1000 mg/kg/day produced no toxicologically significant effects in the parameters measured. The No Observed Adverse Effect Level (NOAEL) and a suitable high dose level for use on future toxicity studies was, therefore, considered to be 1000 mg/kg/day.