Alcohols, C13-15-branched and linear

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(adopted March 22, 1996)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isotridecan-1-ol

EC Number:

248-469-2

EC Name:

Isotridecan-1-ol

Cas Number:

27458-92-0

Molecular formula:

C13H28O

IUPAC Name:

Isotridecanol (reaction product of dodecene)

Specific details on test material used for the study:

- Name of test substance: Tridecanol N
- Degree of purity: 99.9 %
- Physical state / appearance: Liquid / colorless-clear
- Lot/batch No.: continuous production
- Homogeneity: Homogeneous by visual inspection
- Storage conditions: Room temperature, covered with N2
- Stability under test conditions: The stability of the test substance in the vehicle for a time period of 4 hours was confirmed by analysis.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14 - 18 weeks)
- Weight at study initiation: mean(males): 221 g; mean(females): 211 g
- Fasting period before study: yes (Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.)
- Housing: Single housing
- Diet: Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: olive oil Ph.Eur./DAB

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 g/100 ml
- Justification for choice of vehicle: Inhomogeneous in aqueous formulation, solution in olive oil Ph.Eur/DAB.

MAXIMUM DOSE VOLUME APPLIED: 5 ml /kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2000 mg/kg body weight (limit test) has been chosen in the first step with 3 female animals. As none of those animals died, 2000 mg/kg body weight were administered to 3 male animals in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 male and 3 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing:
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals;
Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes (Necropsy with gross-pathology examination on the last day of the observation period after killing with C02.)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: - Male animal symptoms: sign of toxicity noted in the 2000 mg/kg administration group was piloerection and was observed on hour 5 after administration. - Female animal symptoms: no signs of toxicity were observed during clinical examination in the 2000 mg

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (3 males and 3 females) examined at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met