Dec-9-en-1-ol

Endpoint summary

Description of key information

Acute toxcity: Oral

LD₅₀ > 10000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 January 1982 - 25 January 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

other: Acute Oral Toxicity Testing in Rodents, January 1981

Deviations:

not specified

GLP compliance:

not specified

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: males: 170 - 247 g / females: 159 - 244 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 3 with wire mesh tops and standardized granulated soft wood bedding
- Diet (e.g. ad libitum): stadard pelleted food, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 week under test conditons

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours/day

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

Volume/kg bodyweight:
10 mL at 1000 mg/kg
20 mL at 5000 mg/kg
20 mL at 10000 mg/kg

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the day of administration, 7 and 14 days after the administration
- Necropsy of survivors performed: yes
- Other examinations performed: General behaviour, nose, respiration, motility, eye, body position, motor susceptibility, skin, clinical signs, gross pathology.

Statistics:

No statistical model was used to determine LD50.

Preliminary study:

not specified

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: The main symptoms observed were: sedation, dyspnoea, curved body position, diarrhoea and ruffled fur. These symptoms were more pronounced in the higher groups.

Gross pathology:

No pathological changes at any dose.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test item in rats of both sexes observed over a period of 14 days was estimated to be greater than 10000mg/kg.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

One reliability 2 study available.