Registration Dossier

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 according OECD 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
500 µl of the test substance formulated in glycerin were placed on a plaster and applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Macrolex Blau CA 51056 = CAS 41611-76-1
pH-value: 7.0 (20 g/l H2O)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with an electrical hair clipper
Vehicle:
other: glycerin
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h and 7 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h and 7 days
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point

Any other information on results incl. tables

No erythema and no edema was observed. Score = 0 at any time point

Applicant's summary and conclusion

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

500 µl of the test substance formulated in glycerin were placed on a plaster and applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water.

No erythema and no edema was observed. Score = 0 at any time point. Macrolex Blau CA 51056 is not irritating to the skin (exposure time = 4 hours).