3,7,11-Trimethyldodec-1-en-3-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,7,11-trimethyldodec-1-en-3-ol

EC Number:

609-221-2

Cas Number:

3625-46-5

Molecular formula:

C15H30O

IUPAC Name:

3,7,11-trimethyldodec-1-en-3-ol

Test material form:

liquid

Details on test material:

Tetrahydronerolidol (THNER)
CAS No. 3625-46-5
Batch No.: Anlage 067, 13 Jun 2001
Purity: 96 %

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg

VEHICLE
- Concentration in vehicle: 40 g/ 100 ml

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals per sex

Control animals:

no

Details on study design:

- Observation times: 1, 24 and 48 h, 7 and 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

no mortality observed

Mortality:

no mortality observed

Clinical signs:

Males: General poor condition, dyspnea, lateral position, smudgy fur. Syptoms were observed on day one after treatment.
Females: Impaired and poor general condition, dyspnea, prone position, lateral position, tumbling, ruffled and smudgy fur, diarrhea. Symptoms were observed after one hour until day one after treatment.

Gross pathology:

Necropsy: no effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the test substance did not induce mortality at the dose tested and thus, the LD50 is >2,000 mg/kg. No classification of the test substance is necessary.

Executive summary:

The acute oral toxicity test in rats was performed to investigate the toxic potential of the test substance in three male and three female rats at a concentration of 2,000 mg/kg. The stability of the test substance in the vehicle used, here olive oil Ph.Eur./DAB, was analyzed with the GC-analysis with external calibration. Results demonstrated that the test substance in olive oil was stable over a period of 4 hours. The test substance was applied orally via gavage and animals were observed for clinical signs after 1 h, 24 h, 48 h, 7 d, and 14 d. Both, male and female animals showed various clinical signs after administration, such as general poor condition, dyspnea, and lateral position. Symptoms in males were observed on day 1 after administration and in females after one hour post-administration until day 1. No mortality was observed. No alterations in organs was observed.