Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-04-07 to 2008-04-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
, adopted 2001-12-17
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2007-10-15
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Chemical name: 5-Cyclohexyl-2-methyl-pentan-1-ol
- Empirical formula: C12H24O
- Molecular weight: 184.3 g/mol
- Physical state: liquid, clear colourless to pale yellow

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 212 - 242 g
- Fasting period before study: an overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing: the animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (ad libitum, exception see "Fasting period before study" above): Certified Rat and Mouse diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Relative humidity: 30 to 70 %
- Air exchanges: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
SIGHTING STUDY / MAIN STUDY
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. A single animal was treated as follows: dose level: 2000 mg/kg; specific gravity: 0.892; dose volume: 2.25 mL/kg. In the absence of mortality at a dose level of 2000 mg/kg, an additional group of four animals was treated as follows: dose level: 2000 mg/kg; specific gravity: 0.892; dose volume: 2.25 mL/kg. A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

MAXIMUM DOSE VOLUME APPLIED: 2.25 mL/kg

DOSAGE PREPARATION: the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
Doses:
2000 mg/kg bw. (sighting study / main study)
No. of animals per sex per dose:
5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Preliminary study:
2000 mg/kg bw:
- no deaths were recorded.
- animal had diarrhoea during the day of dosing. No other signs of systemic toxicity were noted during the study.
- animal gained the expected gains in body weight over the observation period.
- no abnormalities were noted at necropsy
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Two animals had diarrhoea during the day of dosing. No other signs of systemic toxicity were noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route, as well.

Categories Display