Octane-1,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization. Study is adequate for assessment with acceptable restrictions. Purity and stability of the test material were the responsibility of the sponsor and therefore were not reported for the batch of test material used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

of 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

of 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octane-1,2-diol

EC Number:

214-254-7

EC Name:

Octane-1,2-diol

Cas Number:

1117-86-8

Molecular formula:

C8H18O2

IUPAC Name:

octane-1,2-diol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sprague Dawley rats, strain: Crl:CD BR with appropriate range of bodyweight at study start.
- Source: Charles River UK Ltd., Margate, Kent, UK.
- Age at study initiation (day of dosing): 8 to 12 weeks.
- Weight at study initiation (day of dosing): Males: minimum 219 g, maximum 231 g,
Females: minimum 216 g, maximum 230 g.
- Housing: Group housing with up to 5 animals by sex in solid-floor propylene cages.
- Bedding material: Woodflakes.
- Fasting period: Overnight immediately prior to dosing until 3-4 hours after dosing.
- Diet (ad libitum, except for fasting period): Commercially available standard laboratory animal diet:
Rat and Mouse Expanded Diet No. 1 from Special Diets Services Limited, Witham, Essex, UK.
- Water (ad libitum*): Mains drinking water
- Acclimation period: At least 5 days before start of dosing.

* Remark: The study report does not clearly state whether or not water was supplied during the fasting period.

ENVIRONMENTAL CONDITIONS

The animal room was maintained at:
- Temperature (°C): 20 ± 1°C
- Relative Humidity (%): 42 to 67%
- Photoperiod (artificial lighting): 12 h day / 12 h night
- Rate of air exchange: Ca. 15 changes/h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Remarks:

BP

Details on oral exposure:

VEHICLE
- Concentration of test material in vehicle: 200 mg/ml
- Amount (dose volume by gavage): 10 ml/kg bw
(individual dose volume was calculated based on individual fasted bodyweight at the time of dosing).

DOSAGE PREPARATION:
The dose formulation was freshly prepared by mixing the test material with the vehicle. A suspension was formed.
Homogeneity was assured by use of a Silverson Homogeniser and vortex mixer.

RATIONALE FOR DOSE SELECTED:
The choice of the limit dose of 2000 mg/kg bw was appropriate in the main study, because this dose did not induce any deaths and elicited only transient clinical signs in a preliminary range-finding study with 1 male and 1 female rat observed for 12 days after dosing.

Doses:

2000 mg/kg bw (5 males + 5 females)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observation of clinical signs: 0.5, 1, 2 and 4 h post dosing on the day of administration (Day 0) and subsequently once daily for 14 days.
Weighing of each animal: Day 0 for dose calculation and on Days 7 and 14.
- Necropsy performed: yes, of all main study animals.

Statistics:

Not applicable, as there were no deaths and only one dose group.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at the limit dose of 2000 mg/kg.

Mortality:

Single Dose at Mortality
2000 mg/kg 0/5 (f)
2000 mg/kg 0/5 (m)

Clinical signs:

other: In the main study, clinical signs comprised hunched posture, lethargy, ataxia, decreased respiratory rate and laboured respiration in all animals on the day of dosing (Day 0). By the day afterwards (Day 1) only hunched posture was still seen in four male

Gross pathology:

Necropsy of each animal at the end of the 14-day post treatment observation period did not reveal any macroscopic pathology findings.

Applicant's summary and conclusion

Interpretation of results:

other: no mortality at the limit dose of 2000 mg/kg, no classification according to 1272/2008