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Description of key information

Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg

Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April - May 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
2 x 3 animals
Control animals:
no
Details on study design:
16-24h fasting pre-dosing, feeding 2-4h after oral gavage
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortalities
Clinical signs:
other:

The clinical signs were decreased motility and uncoordinated gait.

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
the test item is of low acute oral toxicity
Executive summary:

A dose of 2000 mg/kg body weight was tolerated by female rats without mortalities, effects on weight gain and gross pathological findings.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March - May 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortalities occured
Clinical signs:
other:

The following local clinical sign was observed: partial reddening of the test area.


There were no toxicological effects on body weight or body weight development in males. In one female a decrease in body weight gain was observed in the first week.


The necropsies performed at the end of the study revealed no particular findings.

Interpretation of results:
GHS criteria not met
Conclusions:
the test item is of low acute dermal toxicity
Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test compound applied semiocclusively for 24 hours.


Based on the present investigations, 4-Methoxycyclohexanone is to be regarded to have the following LD50 values:
LD50 rat, male : > 2000 mg/kg body weight; rat, female : > 2000 mg/kg body weight


So it is regarded as very low toxic after dermal application.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
Klimisch 1

Additional information

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.