Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No information on test substance purity was given, limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no information about test substance purity, limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
EC Number:
947-716-8
Molecular formula:
C15H30O
IUPAC Name:
Reaction mass of 1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol and 1-[(1S*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 145 - 190 g (7 days prior to dosage)
- Fasting period before study: approx. 16 h prior to dosage
- Housing: groups of five in plastic cages (42 x 26 x 14 cm), wood chip bedding
- Diet: pelleted Sniff Standard diet, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20
- Humidity (%): 50
- 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: 20 mL/kg bw


Doses:
20 mL/kg bw (corresponding to 18000 mg/kg bw based on a density of 0.9 g/cm³)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosage, and at least once daily thereafter for a total of 14 days. Body weights were recorded on the day of administration and on day 14 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Statistical analysis of the mortality data was performed by the Litchfield & Wilcoxon in combination with the Gaussian Integral.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 18 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The original LD50 value of > 20 mL/kg bw was recalculated based on the density of 0.9 g/cm3.
Mortality:
No mortality occurred during the study period.
Clinical signs:
All animals exhibited disturbances in coordination, diarrhea and piloerection beginning within 3 h after dosage and persisting for 24 h. At the 48 h evaluation and throughout the remainder of the study all the animals generally exhibited normal appearance and behavior.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsies performed on the animals at termination exhibited no gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value > 20 mL/kg bw (corresponding to > 18000 mg/kg bw based on a density of 0.9 g/cm³) in male and female rats was found.
Executive summary:

The acute oral toxicity of the test substance was assessed in a study similar to OECD Guideline 401 (1977). A total dose of 20 mL/kg bw (equivalent to 18000 mg/kg bw based on a density of 0.9 g/mL; limit test) test substance was administered to 10 male and 10 female rats by gavage. Animals were observed for mortality and general clinical condition on the day of administration and once daily thereafter for 14 days. Body weights were recorded on the day of administration and on day 14 thereafter. Gross necropsy was performed at the end of the observation period at terminal sacrifice. None of the animals died during the study and the body weight gain was not affected by the administration of the test substance. All animals exhibited disturbances in coordination, diarrhea and piloerection beginning within 3 h after dosage and persisting for 24 h. No pathological findings were observed at necropsy. Based on the results of this study, the oral LD50 value was determined to be > 20 mL/kg bw (equivalent to > 18000 mg/kg bw based on a density of 0.9 g/mL) in rats.

Categories Display