1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-06-22 to 1999-11-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-

EC Number:

611-799-6

Cas Number:

59121-99-2

Molecular formula:

C15H24O

IUPAC Name:

1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight; (150g - 300g) (+/- 20% of the mean weight)
- Fasting period before study: The animals were given no feed at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in steinless steel wire mesh cages, type DK-III, Becker & Co., Castrop-Rauxel, FRG
- Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes: Fully air conditioned rooms
- Photoperiod: 12 / 12 (h dark / h light) (6.00 a.m.- 6.00 p.m. / 6.00 p.m. - 6.00 a. m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40.000 g/100 mL
- Justification for choice of vehicle: Good solubility in olive oil

MAXIMUM DOSE VOLUME APPLIED: 5.00 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw has been chosen in a first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw have been tested in a second step with animals of the other sex (3 male rats).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 x female
3 x male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Weighing shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). 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 at the last day of the observation period. Withdrawal of food at least 16 hours before killing with C02; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible.
- Other examinations performed: clinical signs, body weight, grosspathology examination

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality occured in both test groups.

Clinical signs:

Number of male animals showing symptoms:
Dose (mg/kg bw): 2000
No. of animals: 3
Impaired general state: 3
Poor general state: 1
Dyspnoea: 3
Apathy: 1
Abdominal position: 3
Staggering: 3
Piloerection: 3
Smeared fur: 1

Number of female animals showing symptoms:
Dose (mg/kg bw): 2000
No. of animals: 3
Impaired general state: 3
Poor general state: 1
Dyspnoea: 3
Apathy: 1
Staggering: 3
Diarrhea: 1

Body weight:

The expected body weight gain was observed in the course of the study.

Gross pathology:

No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU