Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
no data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The results are not enough detailed to conclude and propose a classification

Data source

Reference
Reference Type:
publication
Title:
Range finding toxicity data, list III
Author:
Smyth HF, Carpenter CP, Weil CS
Year:
1949
Bibliographic source:
J Ind Hyg Tox 31: 60-61

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Similar to the standard guideline except for the number of observations.
More details on the method are given in previous publications. These details have been added hereafter.
The publications are:
Smyth & Carpenter (1944): The place of the range-finding test in the industrial toxicology laboratory. J Ind Hyg Tox 26: 269-273
Smyth & Carpenter (1948): Further experience with the range finding test in the industrial toxicology laboratory. J Ind Hyg Tox 30: 63-68
GLP compliance:
no
Remarks:
Test performed before the GLP creation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals

Species:
rabbit
Strain:
other: albino, no further data
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 mL


VEHICLE: none
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
5
Details on study design:
no data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
6
Max. score:
10
Reversibility:
no data
Irritant / corrosive response data:
According to the criteria showed above, necrosis is produced

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results are not enough detailed, to propose a conclusion
Executive summary:

The irritation effects of DES have been studied in a test with 5 rabbits exposed for 24 h to 0.01 mL of the test substance.

The effects were observed at 24 h only. Necrosis was observed (score of 6 on a scale from 1 to 10).