Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP status unknown, near guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexane
EC Number:
203-806-2
EC Name:
Cyclohexane
Cas Number:
110-82-7
Molecular formula:
C6H12
IUPAC Name:
cyclohexane
Details on test material:
No details reported

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No details reported

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
Not reported
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Animals were observed 1, 2 and 4 hours on the day of application and daily thereafter for a further 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortalities
Mortality:
No mortalities.
Clinical signs:
All rabbits vocalised as test substance applied. No other clinical observations observed.
Body weight:
All gained weight during the study.
Gross pathology:
No abnormalities.
Other findings:
Dermal irritation: Erythema on day 1 ranged from very slight in 2 males to well-defined in 1 female. On day 3 erythema was very slight in 2 males and 2 females but had cleared by day 7. Oedema on day 1 ranged from very slight in 1 male and 3 females to slight in 1 male but had cleared by day 3. Scaling was present in 1 female on day 10.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute dermal LD50 of cyclohexane to male and female rabbits was in excess of 2000 mg/kg bodyweight.
Executive summary:

Acute dermal LD50 of cyclohexane to male and female rabbits was in excess of 2000 mg/kg bodyweight.