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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Reliability has been presented as 2 because a protocol somewhat similar to OECD Guideline has been followed but pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-cyclohexylethanol
EC Number:
214-780-7
EC Name:
1-cyclohexylethanol
Cas Number:
1193-81-3
Molecular formula:
C8H16O
IUPAC Name:
1-cyclohexylethanol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 210-225 g; females: 210-245 g
- Fasting period before study: not indicated

IN-LIFE DATES: not specified, all animals were sacrificed at the end of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE APPLIED: 2510 mg/kg bw
Doses:
1260, 1580, 2000 and 2510 mg/kg bodyweight
No. of animals per sex per dose:
1260 mg/kg bw: 3 males, 2 females
1580 mg/kg bw: 2 males, 3 females
2000 mg/kg bw: 3 males, 2 females
2510 mg/kg bw: 2 males, 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 100 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 950 - <= 2 260
Mortality:
At the lowest dose, no animal died while at the highest dose all animals (2 males and 3 females) died. At 1580 mg/kg bw, out of the two males and the three females tested, one male died. At 2000 mg/kg bw, from the three males and the two females tested, two males died. Mortality occured in one to six days, mostly within one day.
Clinical signs:
Reduced appetite and activity (one to three days in survivors), increasing weakness, ocular discharge and collapsing occured.
Gross pathology:
The animals who died during the study showed lung hyperemia, discoloration in areas of the liver and gastrointestinal inflammation. The animals who survived during the study showed normal viscera.
Other findings:
Male animals seemed to be more sensitive since 1 out of 2 and 2 out of 3 male animals tested, died at dose levels of 1580 and 2000 mg/kg bw, respectively, while no female animals died at these doses. Due to limited animal numbers it is justified to add the results of males and females per dose, resulting in an LD50 of 2100 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified, criteria not met
Remarks:
according to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
In the acute oral toxicity test the substance showed an LD50 of 2100 mg/kg bw for male and female animals combined.
Executive summary:

An acute oral toxicity study was performed somewhat similar to OECD TG 401. Five rats per group (2 or 3 males and 2 or 3 females) were exposed to the substance in dose levels of 1260, 1580, 2000 and 2510 mg/kg bodyweight and observed for 14 days. At the lowest concentration no animal died, while at the highest concentration all animals died. Male animals seemed to be more sensitive since 1 out of 2 and 2 out of 3 male animals tested, died at dose levels of 1580 and 2000 mg/kg bw, respectively, while no female animals died at these doses. Mortality was observed in one to six days, mostly within one day. Clinical signs included reduced apetite and activity (one to three days in survivors), increasing weakness, ocular discharge and collapsing. At the end of the study, necropsy was performed on the surviving animals which showed normal viscera. Necropsy on animals that died during the study showed lung hyperemia, discoloration in areas of the liver and gastrointestinal inflammation. Due to the limited animal numbers it is justified to add results of males and females per dose, resulting in an LD50 of 2100 mg/kg bw.