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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-08-10 until 2012-10-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
4-Cyclohexan-1-ol, dodecyl-, branched
EC Number:
938-702-2
Molecular formula:
not applicable UVCB
IUPAC Name:
4-Cyclohexan-1-ol, dodecyl-, branched
Details on test material:
- Name of test material (as cited in study report): Cyclohexanol, 4-C11-12-alkyl, branched
- Physical state: liquid
- Analytical purity: 97 wt. %
- Impurities (identity and concentrations): not mentioned
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: female: 149 - 179 g
- Fasting period before study: 16 - 19 h (access to water was permitted)
- Housing: in groups in IVC cages, type III H, polysulphone cages on Altromin Altromin saw fibre bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice (lot no. 856)
- Water: ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: at least 5 days
The animals were non-pregnant and nulliparous.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 1. and 2. step: 0.3 g of the test item were suspended in the vehicle to gain a final volume of 10 mL and to achieve a dose of 300 mg/kg/f at a dose volume of 10 mL/kg body weight, 3. step: 1 g of the test item was suspended in the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose of 10 mL/kg body weight. For all animals of the fourth step, 1.5 g of the test item were suspended in the vehicle to gain a final volume of 7.5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characterics
- Lot/batch no. (if required): Sigma, lot MKBJ0602V, expiry date 08/2013
- Purity: not mentioned
Doses:
300; 2000 mg/kg bw
No. of animals per sex per dose:
6 (3 in each of the 2 steps)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 prior to the administration and on days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrified by an over-dosage of phenobarbital.
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
not performed

Results and discussion

Preliminary study:
not ementioned
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none animals died
Clinical signs:
at 300 mg/kg bw/d there were no signs of toxicity, after 2 h 3 animals showed slight piloerection
at 2000 mg/kg bw/d after 30 minutes there were no signs of toxicity, after 2 and 3 h slight piloerection was seen in all six animals, 3 animals showed slightly reduced spontaneous activity and bradykinesia after 4 h, after 5 hours the 3 animals showed moderately reduced spontaneous activity and moderate piloerection and d 2 until the end of the observation period no signs of toxicity were seen in all animals.
Body weight:
none of the animals showed weight loss during the observation period
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Other findings:
- Organ weights: Not reported
- Histopathology: Not reported
- Potential target organs: Not reported
- Other observations: Not reported

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No animal died. In the study performed the dosis letalis media (LD50) to rats of Cyclohexanol, 4-C11-12-alkyl, branched was found to be > 2000 mg/kg bodyweight.
Executive summary:

The median lethal dose of Cyclohexanol, 4-C11-12-alkyl, branched after a single oral administration to female rats, observed over a perid of 14 days is LD50 > 2000 mg/kg. At a dose of 300 mg/kg bw/d after 2 h 3 animals showed slight piloerection. At 2000 mg/kg bw/d after 30 minutes there were no signs of toxicity, after 2 and 3 h slight piloerection was seen in all six animals, 3 animals showed slightly reduced spontaneous activity and bradykinesia after 4 h, after 5 hours the 3 animals showed moderately reduced spontaneous activity and moderate piloerection and d 2 until the end of the observation period no signs of toxicity were seen in all animals. None of the animals showed weight loss during the observation period.

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