Registration Dossier

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:
other: GLP 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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test substance: Tridecanol A

- Degree of purity: 99.95 area-%

- Physical state / appearance: Liquid / colorless - clear

- Homogeneity: Homogeneous by visual inspection.

- Substance No.: 01/0324-1

- Batch No.: from continuous production

- Storage conditions: Room temperature, covered with N2

- Stability: The stability under storage conditions over the exposure period was guaranteed by the sponsor. 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:
- Animal species / strain / quality: Rat / Wistar / CrIGIxBrIHan:WI ; the female animals were nulliparous and non-pregnant;

- Origin: Charles River Deutschland GmbH, Sulzfeld, Germany;

- Age of the animals: Young adult animals (male animals approx. 8- 12 weeks, female animals approx. 14 - 18 weeks);

- Animal weights at start of the study: Animals of comparable weight (± 20% of the mean weight): mean(males): 225 g; mean(females): 206 g;

- Fasting period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.

- Acclimatization period: Acclimatization for at least 1 week;

- Room temperature / relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.

- Day / night rhythm: 12h/12h (6.00 am - 6.00 pm / 6.00 pm - 6.00 am);

- Type of cage: Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG);

- No. of animals per cage: Single housing;

- Animal identification: Individual identification by cage cards and tail marking.

- Bedding: No bedding in the cages; wood shavings in the waste trays;

- Drinking water: Tap water ad libitum;

- Diet: Kliba-Labordiet, Provimi Kliba Sa, Kaiseraugst, Switzerland, ad libitum;

- Analysis of drinking water: The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF Aktiengesellschaft as well as for the presence of microbes by a contract laboratory.

- Analysis of feed: The feed used in the study was assayed for chemical and microbiological contaminants.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil (Ph.Eur/DAB)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/100ml

- Justification for choice of vehicle: Inhomogeneous in aqueous preparations; solution in olive oil Ph.Eur/DAB;

MAXIMUM DOSE VOLUME APPLIED: 5ml/kg

DOSAGE PREPARATION: The test substance preparation was produced for each administration group shortly before administration in olive oil Ph.Eur./DAB by stirring with a magnetic stirrer. Homogenization until end of each administration period: By stirring with a magnetic stirrer.

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
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 14 days

- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study; recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals; 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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
Male animal symptoms:
Sign of toxicity noted in the 2,000 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 this 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