Alcohols, C9-11-branched and linear

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03.11.1980-

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Method: other: regulatory procedure

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C9-11-branched and linear

EC Number:

288-284-4

EC Name:

Alcohols, C9-11-branched and linear

Cas Number:

85711-26-8

Molecular formula:

C9H20O, C10H22O and C11H24O

IUPAC Name:

Alcohols, C9-11-branched and linear

Test material form:

other: moderately viscous liquid

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Portage, Michigan, US
- Age at study initiation: Not reported.
- Weight at study initiation: males 213.9 + or - 8.1g; females 170 + or -  10.4 g (fasted weights for treated animals)
- Fasting period before study: overnight
- Housing: individual polycarbonate/wire mesh cages
- Diet: ad libitum, except during exposure
- Water: yes, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 23.3
- Humidity (%): average 54.9
- 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: 5ml/kg

Doses:

5 ml/kg

No. of animals per sex per dose:

5M, 5F

Control animals:

yes

Remarks:

5M+5F receiving 5 ml/kg distilled water.

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed:  All rats were necropsied at the end of the  observation period.
- Other examinations performed: Clinical signs were recorded hourly for 6 hours after  dosing then at 24 hours and twice daily throughout the 14-day observation  period.  Body weights were recorded the day before dosing and at 7 and 14 days. A fasted body weight was taken prior to dosing and used for  calculation of the dosage.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 4000 mg/kg bw based on the lower value of density range, 0.8 g/cm3)

Mortality:

There were no mortalities in either test or control animals.

Clinical signs:

other: All treated animals had diarrhoea at 0.5 -1.5 hours after  dosing, while 4/5 males and all females had polyuria by 24 hours after  dosing. Among control animals one female had polyuria. All animals  appeared normal by 54 hours post-dosing. The only other 

Gross pathology:

There was no observable pathology in either test or  control animals.

Other findings:

POTENTIAL TARGET ORGANS: No conclusions.
SEX-SPECIFIC DIFFERENCES: None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity study for Alcohols, C9-11 branched and linear, conducted according to a protocol similar to the now-deleted OECD Test Guideline 401 and in compliance with GLP, reports an LD50 value of >4000 mg/kg bw.