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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1943
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Duration only 6 days and at a single dose level with mortality. Only a single animal used. Insufficient information on substance identity and purity.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1943

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The anterior abdominal wall of a white rabbit was clipped. The compound was dropped onto the skin in two applications, and removed by washing with soap and water after the second application. Dosing was carried out daily for a period of 6 days, at a single dose level.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylcyclohexanone
EC Number:
209-665-3
EC Name:
4-methylcyclohexanone
Cas Number:
589-92-4
Molecular formula:
C7H12O
IUPAC Name:
4-methylcyclohexan-1-one
Constituent 2
Reference substance name:
3-methylcyclohexanone
EC Number:
209-710-7
EC Name:
3-methylcyclohexanone
Cas Number:
591-24-2
Molecular formula:
C7H12O
Test material form:
liquid
Details on test material:
- Density: 0.914
- Boiling point: 169-170.5°C
- Refractive index: 1.4458

Test animals

Species:
rabbit
Strain:
other: white
Sex:
not specified
Details on test animals or test system and environmental conditions:
Obtained from local breeders.

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: 24 square inches
- Time intervals for shavings or clipplings: not reported

REMOVAL OF TEST SUBSTANCE
- Washing (if done): soap and water
- Time after start of exposure: 30min after second application

TEST MATERIAL
- Amount applied: 5mL per application, total of 10mL per day

USE OF RESTRAINERS FOR PREVENTING INGESTION: yes, possibly also in a hood to prevent inhalation
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
6 days
Frequency of treatment:
Daily, with two application separated by 30min
Doses / concentrationsopen allclose all
Dose / conc.:
5 other: mL
Remarks:
Per application
Dose / conc.:
10 other: mL
Remarks:
Per day
Dose / conc.:
18 800 mg/kg bw/day (nominal)
Remarks:
Total dose over 6 days
No. of animals per sex per dose:
Single animal
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Narcosis, tremors and convulsive movements were observed.
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
Irritation of skin and hemorrhagic areas.
Mortality:
mortality observed, treatment-related
Description (incidence):
Death occured 15min after treatment on the 6th day.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Little or no weight loss.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Effects on heart, liver, kidney and vascular degeneration in the lung.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Key result
Dose descriptor:
dose level:
Effect level:
ca. 3 133 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified

Any other information on results incl. tables

Dose level calculated by the registrant based on reported total dose per kg bw, and the duration of 6 days.

Applicant's summary and conclusion

Conclusions:
The study reports repeat dosing via the dermal route in white rabbits, carried out daily for a period of 6 days, at a single dose level of ca. 3133 mg/kg bw.