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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well reported GLP comparable to Guideline study but batch with high impurity used (content only 48.2%)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 12.126
- Batch No.: 15008609
- content after reanalysis: 48.2% (limits of tolerance for the intermediate were 60-102%)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
2 males / 2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
No clinical signs and no effect on body weight development.

Any other information on results incl. tables

Results of the study:

    Test compound ZK 12.126                 Animal number and sex
 Location (finding)  Time-point after end of exposure  281M 268M    288F 297F
 Reddening and scab formation  30 -60 min  0 0 0
   24 hours  0 0 0  
   48 hours  0 0 0  
   72 hours  0 0 0  
Individual mean values:  0 0 0  
 Mean value of all animals:                    0
               
 Swellings  30 -60 min  0  
   24 hours  0  
   48 hours  0  
   72 hours  0  
Individual mean values      0  
Mean values of all animals                   

Applicant's summary and conclusion

Executive summary:

500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 2 males and 2 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.

In this skin irritation study the test substance was not irritating to the skin. However, it must be noted that the reanalysis of the used batch of the substance revealed an actual content of ZK 12.126 of only 48:2%, so that the percentage of impurities in this batch is very high. Nevertheless, the results showed that the local irritation potential of the solid substance of 1,2 -Methylene-4,6 -dien on the skin might be fairly low or even non-existent.