1-Propanol, 2-methyl-3-[(1,7,7-trimethylbicyclo[2.2.1]hept-2-yl)oxy]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 4 March and 25 March 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

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:

-

EC Number:

416-210-4

EC Name:

-

Cas Number:

128119-70-0

Molecular formula:

C14H26O2

IUPAC Name:

2-methyl-3-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-1-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Equal numbers of healthy male and female CD rats of Sprague-Dawley origin (Hsd/Ola:SpragueDawley(CD)) were obtained from Harlan Olac Ltd., Bicester, Oxon, England.
They were in the weight range of 105 to 133 g and approximately four to seven weeks of age prior to dosing (Day 1) in the main study. All the rats were acclimatised to the experimental environment for a period of seven days prior to the start of the main study.
The rats were allocated without conscious bias to cages within the treatment group. They were housed in groups of up to five rats of the same sex in metal cages with wire mesh floors in Building R 14 Room 6.
A standard laboratory rodent diet (Biosure LAD 1) and drinking water were provided ad libitum.
Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
The batch(es) of diet used for the study was analysed for certain nutrients, possible contaminants and micro-organisms.
Results of routine physical and chemical examination of drinking water at source, as conducted, usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd.
The mean daily minimum and maximum temperatures of the animal room were 20°C and 22°C respectively and the mean daily relative humidity value was 51 % R. H. Air exchange was maintained at 10 to 15 air changes per hour and lighting was controlled by means of a time switch to provide 12
hours of artificial light (0700 - 1900 hours) in each 24-hour period.
Each animal was identified by cage number and ear punching. Each cage was identified by a coloured label displaying the dose level, study schedule number, animal mark and the initials of the Study Director and Home Office licensee.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The appropriate dose volume of the test substance was administered to each rat by oral gavage using a syringe and plastic catheter (8 choke).

Doses:

2.0 g/kg bodyweight

No. of animals per sex per dose:

- A preliminary study was carried out by dosing two male and two female rats at 800 mg/kg bw.
- A group of ten rats (five males and five females) was treated at 2.0 g/kg bw.

Control animals:

no

Details on study design:

OBSERVATIONS
- Mortality: Cages of rats were checked at least twice daily for any mortalities.
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of seven hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week
days or 11. 30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation.
The animals on the preliminary and main studies were observed for 5 and 14 days respectively after dosing.
- Bodyweight: The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes were calculated.
- Termination: All were killed by cervical dislocation.
- Macroscopic pathology: All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.

Results and discussion

Preliminary study:

The results of the preliminary study indicated that the acute lethal oral dose to male and female rats of Bornafix was greater than 800 mg/kg bodyweight.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral dose of Bornafix at 2.0 g/kg bodyweight.

Clinical signs:

other: Pilo-erection and increased salivation were observed in all rats within three minutes of dosing. Piloerection persisted throughout the remainder of D ay 1 and was accompanied at later intervals on Day 1 by abnormal body carriage (hunched posture) and diar

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful in accordance with EU CLP (EC No 1272/2008 and its amendments)

Conclusions:

In an acute oral toxicity test in male and female rats, an LD50 of > 2000 mg/kg bw was determined.

Executive summary:

A study according to OECD guideline 401 was performed to assess the acute oral toxicity of Bornafix to the rat. A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, as supplied, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths. Clinical signs of reaction to treatment were limited to pilo-erection, abnormal body carriage (hunched posture), diarrhoea and increased salivation; recovery was complete by Day 2. All rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal oral dose to rats of Bornafix was found to be greater than 2.0 g/kg bodyweight.