Registration Dossier

Toxicological information

Skin irritation / corrosion

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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: Scientifically reliable study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
No further information available.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No further information available.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: In individual cages in air-conditioned spaces (Battery cages
- Diet: Altromin 2123 Haltungsdilt - rabbits Altromin GmbH Lage / Lippe, ad llbitum and hay (about 15g)
- Water: deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 50 +/-20 %
- Photoperiod: 12 hours a day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Dorsal area
Duration of treatment / exposure:
4 hours
Observation period:
No further information available.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

 Time after removal of patch  30 - 60 minutes  24 hours  48 hours  72 hours
 Animal number  1, 2 & 3  1, 2 & 3  1, 2 & 3  1, 2 & 3
Erythema and eschar   0, 0, 0  0, 0, 0  0, 0, 0  0, 0, 0
 Edema  0, 0, 0  0, 0, 0  0, 0, 0  0, 0, 0

Applicant's summary and conclusion

Interpretation of results:
no data
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Executive summary:

In a well reported guideline study skin irritation study, no effect were seen with the substance 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol.