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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-07-21 to 2003-08-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
α-methylcyclohexanepropanol
EC Number:
234-091-5
EC Name:
α-methylcyclohexanepropanol
Cas Number:
10528-67-3
Molecular formula:
C10H20O
IUPAC Name:
4-cyclohexylbutan-2-ol

Test animals

Species:
rat
Strain:
other: Shoe:WIST
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 140 - 160 g b. w
- Housing: 2-3 per cage, macrolone type III, floor area 810 cm2
- Diet: ad libitum, Altromin 1314 from Altromin, D-32791 Lage, Lippe
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation: 30 min, 2, 4 and 6 h after application and daily for 14 days; weighing: body weight was recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
No data provided

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Hunched posture and piloerection for up to 6 h after treatment.
Body weight:
A normal body weight gain was observed.
Gross pathology:
No pathological abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 in this study with rats was determined to be > 2000 mg/kg b.w..
Executive summary:

An acute oral toxicity using the class method according to OECD 423 was conducted. 2000 mg/kg b.w. of the test substance were administered to 6 female rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. The test substance produced slight signs of toxicity like a hunched posture and piloerection for up to 6 h after treatment. No mortality was observed and the animals showed a normal body weight gain during the study. Therefore the acute oral LD50 in this study was determined to be > 2000 mg/kg b.w. in rats.