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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limit test with 10 males
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
2,6-dimethyloctan-2-ol
EC Number:
242-361-9
EC Name:
2,6-dimethyloctan-2-ol
Cas Number:
18479-57-7
Molecular formula:
C10H22O
IUPAC Name:
2,6-dimethyloctan-2-ol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals (received on August 3, 1982)
- Weight at study initiation: 224-297 g
- Fasting period before study: 16-20 hours prior to dosing
- Housing: 5 animals per cage in suspended wire mesh cages.
- Diet (e.g. ad libitum): fresh Purina rat chow (Diet #5012) ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.81 mL
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed 3-4 hours post dosing and once daily after for 14 days for mortality, toxicity and pharmocological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
All animals suffered from flaccid muscle tone and lethargy, other signs observed in the animals were ataxia (9 animals), chromorhinorrhea (4), chromodacryorrhea (1), ptosis (1), brown staining of the anogenital area (3).
Gross pathology:
No abnormalities were found.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria (1272/2008/EC and its updates)
Conclusions:
Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
Executive summary:

An acute oral toxicity study was performed according to a method similar to OECD TG 401. In this study, 10 rats were administered Tetrahydromyrcenol at dose levels 5000 mg/kg bw. The mortality rate of the rats was 0/10. Clinical signs observed were flaccid muscle tone and lethargy, ataxia, chromorhinorrhea, chromodacryorrhea, ptosis and brown staining of the anogenital area. Gross necropsy was performed at end of term, but no abnormalities were found. Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.