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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Rats were dosed at 1.22, 1.95, 3.12, 5 g/Kg
GLP compliance:
no
Remarks:
Test performed prior to the GLP guideline
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-sec-butylcyclohexan-1-one
EC Number:
238-830-2
EC Name:
2-sec-butylcyclohexan-1-one
Cas Number:
14765-30-1
Molecular formula:
C10H18O
IUPAC Name:
2-(butan-2-yl)cyclohexan-1-one
Specific details on test material used for the study:
Sample marking: 77-182, Freskomenthe

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
1.22 mg/kg
1.95 mg/kg
3.12 mg/kg
5.00 mg/kg
No. of animals per sex per dose:
10 males per group (per dose)
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 400 mg/kg bw
Based on:
test mat.
95% CL:
ca. 1 900 - ca. 3 000
Remarks on result:
other: 95% confidence limits
Mortality:
1220 mg/kg - 0/10 animals died.
195 mg/kg - 4/10 animals died.
3120 mg/kg - 8/10 animals died.
5000 mg/kg - 10/10 animals died.
Clinical signs:
other: All doses: lethargy, ataxia, coma, ptosis, piloerection, diarrhea (see details in "Any other information on results" field below)
Gross pathology:
not specified
Other findings:
not specified

Any other information on results incl. tables

Dose: 1.22 g/kg; clinical signs:

 Clinical signs observed included lethargy, ataxia, coma, ptosis, chromorhinorrhea, piloerection, diarrhea and chromodacryorrhea. Necropsy revealed 9/10 animals were normal; red exudate in the nose/mouth in 1/10 animals.

Dose: 3.12 g/kg clinical signs; lethal

8/10 deaths; Deaths occurred on days 1 and 2. Clinical signs observed included coma, prostration, ataxia, chromorhinorrhea, chromodacryorrhea, lethargy, diarrhea and emaciation. Necropsy revealed 2/10 animals were normal; red exudate in the nose/mouth in 8/10 animals; brown anogenital exudate in 3/10 animals; red areas in the intestines in 8/10 animals; yellow areas in the intestines in 8/10 animals; gelatinous intestines in 3/10 animals; bloated intestines in 5/10 animals; yellow fluid in the intestines in 3/10 animals; red areas in the stomach in 5/10 animals; mottled liver in 8/10 animals; dark areas in the lungs in 8/10 animals; mottled kidney in 7/10 animals; white nodule on the outer surface of the kidney in 1/10 animals; dark spleen in 3/10 animals; mottled spleen in 5/10 animals; creamy yellow fluid in stomach in 2/10 animals.

Dose: 1.95 g/kg clinical signs; lethal

4/10 deaths; Deaths occurred on days 2 and 12. Clinical signs observed included coma, prostration, ataxia, chromorhinorrhea, diarrhea, chromodacryorrhea, ptosis and emaciation. Necropsy revealed 3/10 animals were normal; 1/10 animals cannibalized; red exudate in the nose/mouth in 3/10 animals; yellow exudate in the nose/mouth in 2/10 animals; brown anogenital exudate in 3/10 animals; red areas in the intestines in 3/10 animals; yellow areas in the intestines in 3/10 animals; gelatinous intestines in 3/10 animals; orange fluid in the stomach in 2/10 animals; yellow fluid in the stomach in 1/10 animals; mottled liver in 3/10 animals; dark lungs in 3/10 animals; dark kidney in 4/10 animals; mottled kidney in 1/10 animals; mottled spleen in 3/10 animals; bladder-blood contained in urine in 1/10 animals.

Dose: 5 g/kg clinical signs; lethal

10/10 deaths. Deaths occurred on days 1 and 2. Clinical signs observed included coma, ataxia, lethargy, ptosis and chromorhinorrhea. Necropsy revealed red exudate in the nose/mouth in 2/10 animals; brown anogenital exudate in 1/10 animals; red areas in the intestines in 5/10 animals; yellow areas in the intestines in 10/10 animals; bloated intestines in 7/10 animals; red areas in the stomach in 9/10 animals; stomach, area approximately 10% bubbled out and thin in 4/10 animals; dark liver in 1/10 animals; mottled liver in 8/10 animals; dark liver in 3/10 animals; dark areas in the lungs in 7/10 animals; mottled kidney in 5/10 animals; pale kidney in 2/10 animals; mottled spleen in 5/10 animals; creamy yellow fluid in the stomach in 7/10 animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
In conclusion the LD50 has been detrmined to be LD50(rat)= 2400 mg/kg bw (1900-3000 mg/kg bw).
Freskomenthe meets the criteria to be classified Category 5 according to the GHS classification.
Executive summary:

LD50 has been detrmined to be LD50(rat)= 2400 mg/kg bw (1900-3000 mg/kg bw).

Freskomenthe meets the criteria to be classified Category 5  according to the GHS classification.