Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975-08-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DOT (Transport-Classification) Guideliens
Deviations:
not specified
Principles of method if other than guideline:
The study was performed before GLP- and OECD-testing guidelines were available and in force. The intact and abraded skin of 6 albino rabbits was employed for this study.
GLP compliance:
no
Remarks:
GLP-guidelines not yet in force at date of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
Physical state: solid
The material to be tested (0.5 mg)

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
4, 24 and 48 hours on intact and abraded skin
Number of animals:
6 albino rabbits were employed for this study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24 and 48 hour
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24 and 48 hours
Score:
0
Max. score:
0
Reversibility:
no data
Other effects:
No data available.

Any other information on results incl. tables

Skin reaction

Reading (hours)

Individual scores – rabbit no. & sex

1

2

3

4

5

6

Erytehma/Eschar

4

24*

48*

72

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Total of *                                     0           0           0            0           0         0

Mean values of *                         0.0         0.0        0.0         0.0       0.0       0.0

Oedema

4

24*

48*

72

0

0

0

 

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Total of *

 

0

0

0

0

0

0

Mean values of *

 

0.0

0.0

0.0

0.0

0.0

0.0

 

Overall mean of * for Erythema/Eschar: 0.0

Overall mean of * for Oedema:               0.0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritation index is 0.0 and therefore, the test item will be not classified as skin irritant to the rabbit skin.
Executive summary:

The study was performed 1975, following the DOT (Transport Classification) Guidelines, before GLP- and OECD-testing guidelines were available and in force and amended in year 1991 (Addendum to Lonza Report No. 0155). A couple of substances were tested in one study. The intact and abraded skin of 6 albino rabbits was employed for this study. A series of 6 rabbits was used for testing each substance. The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape (occlusive application). The material to be tested (0.5 mg) was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

The irritation index is 0.0 and therefore, the test item will be not classified as skin irritant to the rabbit skin.