Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dienyl]phenol
EC Number:
685-515-4
Cas Number:
10309-37-2
Molecular formula:
C18H24O
IUPAC Name:
4-[(1E,3S)-3-ethenyl-3,7-dimethylocta-1,6-dienyl]phenol

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 22.1
- Humidity (%): 55 - 60
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
dose volumn: 10ml/Kg bw
dose level: 2000 mg/kg bw
No. of animals per sex per dose:
6 (2 steps, three animals per step)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2, 4 h after dosing, thereafter, once daily.
- Necropsy of survivors performed: yes
In step - 1, three overnight fasted animals were administered with 2000 mglkg bw.
ln step-2, to confirm the above dose level three more overnight fasted female animals were administered 2000 mg/kg bw.
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
In step 1, no mortality.
In step 2, one mortality on 3th day
Clinical signs:
In step 1, no clinical signs
In step 2, one exhibited clinical signs of toxicity such as piloerection and dullness on day 1 &2, and died on day 3. The other two animals did not exhibit any clinical signs of toxicity during the entire observation period
Body weight:
All the survivors animal showed normal body weight gain during experiment period
Gross pathology:
Gross pathology examination conducted on the animals died during observation period and survived animals on day 14 did not reveal any lesion that could be attributed for the administration of the test substance

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU