Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
500 µl of Macrolex blau RR fl. was applied on a 2.5 x 2.5 cm² area at the shaved trunk of 3 rabbits and fixed semi-occlusively for 24 h. Reading was carried out 1, 24, 48, 72 h and 8 d the application.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
816-119 Macrolex Blau RR fl.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 animals

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
8
Reversibility:
other: score = 0 at any time point if reading was possible

Any other information on results incl. tables

At 1, 24, 48, 72 h a determination of the erythema score was not possible due to substance induced coloration of the skin. At 8 d the score was 0.

Edema score was 0 at any time point (1, 24, 48, 72 h, and 8 d)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

500 µl of Macrolex Blau RR fl. was applied on a 2.5 x 2.5 cm² area at the shaved trunk of 3 rabbits and fixed semi-occlusively for 24 h. Reading was carried out 1, 24, 48, 72 h and 8 d after the application.

At 1, 24, 48, 72 h a determination of the erythema score was not possible due to substance induced coloration of the skin. At 8 d the score was 0. Edema score was 0 at any time point (1, 24, 48, 72 h, and 8 d). The primary irritation index is = 0.

The test substance is classified as non-irritant.