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: early study report; short study description

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-internal standard
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
no data
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
Exposure times: 1 min, 5 min, 15 min and 20 h

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
0
Max. score:
8
Irritant / corrosive response data:
After 1 min, 5 min and 15 min: no irritation.
After 20 hours (back skin): questionable redness.
After 20 hours (ear): light redness.
Skin irritation after 8 days: none.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an old skin irritation study that pre-dates guidelines, rabbit skin was exposed to 2-(2-(2-butoxyethoxy)ethoxy)ethanol for a period of 20 hours . Both dorsal skin and ear tissue was exposed. The dorsal skin showed slight redness but full recovery was observed within 8 days. Whilst the study did not provide the normal level of detail required for comparison with the classification criteria, the level of response seen was sufficiently slight to be able to conclude with certainty that skin irritancy is not an important characteristic of this substance and that is does not meet the criteria for classification as a skin irritant either under the EU or GHS systems.