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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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