Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jul to Aug 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well reported study with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Principles of method if other than guideline:
combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume1.0-1.1 ml) to male and female rats; semi-occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 30-60 min after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 10882
- Batch No.: 15002811, 15002812

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
semiocclusive
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3/sex

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Other effects:
No mortalities occurred. No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.

Any other information on results incl. tables

Local findings:

    Test compound ZK 10882 (2000 mg/kg)                 Animal number and sex
 Location (finding)  Time-point after end of exposure  84M 85M  86M 96F  97F  98F 
 Reddening and scab formation  30 -60 min*  0
   24 hours  0
   48 hours  0
   72 hours  0
Individual mean values:  0
 Mean value of all animals:                    0
               
 Swellings  30 -60 min*  0
   24 hours  0
   48 hours  0 0
   72 hours  0
Individual mean values      0
Mean values of all animals                   

* not included in calculations of mean values

Applicant's summary and conclusion

Executive summary:

The single dermal administration of 6 -Chlor-Chlormethyldien (ZK 10882) to male and female rats at the dose of 2000 mg/kg (corresponding to 206-228 mg ZK 10882/male animal and 196-210 mg ZK 10882/female animal) was tolerated without any mortality.

The test substance was tolerated without any local skin irritations. The mean values of findings (at 24, 48 and 72 h) were 0 for swelling, reddening and scab formation.

No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.