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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(adopted March 22, 1996)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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- Fasting period before study: yes (Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.)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:
- 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/kg administration group.
Body weight:
The mean body weights of the administration groups increased throughout the study period .
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