Cyclohexanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

reliability also questionable since the study has been carried out by IndustrialBioTest Lab. The studies carried out by this lab are potentially invalid due to several shortcomings in study design and reporting (as discovered by FDA in 1976).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Bio-Test lab. internal guidelines

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexanone

EC Number:

203-631-1

EC Name:

Cyclohexanone

Cas Number:

108-94-1

Molecular formula:

C6H10O

IUPAC Name:

cyclohexanone

Details on test material:

TS-Freetext:
Cyclohexanone
CAS No.: 108-94-1

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male/female

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abraded skin

Duration of exposure:

14 days

Doses:

200, 794, 3160 mg/kg

No. of animals per sex per dose:

4

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 794 - < 3 160 mg/kg bw

Mortality:

3160 mg/kg: 4/4; 794 and 200 mg/kg: 0/4

Clinical signs:

other: The test material was severely irritating to the skin of the albino rabbit at the 200 and 794 mg/kg dose levels. Skin changes in rabbits dosed at 200 mg/kg were characterized by pale red erythema and moderate edema at 24 hours; second degree burns, focal

Gross pathology:

Necropsy examination revealed gastroenteritis and hemorrhaging in the colon in rabbit No . 1-M (200 mg/kg) ; red lungs in rabbit Nos . 5-M and 8-F (794 mg/kg); and focal discoloration of the liver and red lungs in rabbit Nos. 9-M and 10-M (3 160 mg/kg). No other gross pathologic alterations were noted except for the local skin changes as previously described.

Any other information on results incl. tables

Mortality and body weights

Dose (mg/kg)	Animal No. and sex	Individual body weights (kg)
		Test day No.
		0	7	14	Number dead/ number tested	Percent dead
200	1 -M	2.56	2.22.	2.24	0/4	0
	2 -M	2.92	2.92	3.06
	3 -F	3.20	3.20	3.50
	4 -F	2.66	2.90	3.00
794	5 -M	3.00	3.10	3.20	0/4	0
	6 -M	2.82	2.98	2.90
	7 -F	3.32	3.30	3.28
	8 -F	3.30	3.42	3.32
3160	9 -M	2.94	(6 h)*	-	4/4
	10 -M	2.72	(6 h)*	-
	11 -F	3.34	(6 -22 h)*	-
	12 -F	2.68	(6 -22 h)*
* time of death

Summary of reactions

	200 mg/kg		794 mg/kg		3160 mg/kg
	Onset	Recovery	Onset	Recovery	Onset	Recovery
Hypoactivity	2 hours	4 hours	1.5 hours	4 hours	0.5 hours	No recovery
Muscular weakness	-	-	1.5 hours	4 hours	1 hour	No recovery
Lacrimation	-	-	1.5 hours	4 hours	1 hour	No recovery
Prostration	-	-	1.5 hours	4 hours	1 hour	No recovery
Anesthesia	-	-	1.5 hours	4 hours	1.5 hours	No recovery
Ataxia	-	-	1 hour	4 hours	1 hour	No recovery
Loss of righting reflex	-	-	1 hour	4 hours	1 hour	No recovery
Salivation	-	-	-	-	1 hour	No recovery
Rhinitis	-	-	-	-	1 hour	No recovery
Labored breathing	-	-	-	-	1 hour	No recovery

Applicant's summary and conclusion

Interpretation of results:

other: harmful