Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-090-2
EC Name:
-
Cas Number:
86087-23-2
Molecular formula:
C4 H8 O2
IUPAC Name:
(3S)-oxolan-3-ol

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4 h
Observation period:
1hr, 4hr, 24hr, 72hr
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
2
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
1
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
At 1 hour, slight erythema was noted in one animal and well
defined erythema in 2 animals. Slight oedema was noted in 2
animals.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize
Conclusions:
1272W94 produced a Primary Irritation Index of 0.3 and was classified as a mild irritant following a 4hr application to rabbit skin according to the Draize classification scheme. 1272W94 did not meet the criteria for classification as irritant according to EU labelling Regulations.
Executive summary:

A study was performed to assess the irritancy potential of 1272W94 to the skin of the New ZealandWhite rabbitt. The method used followe that described in OECD guidelines No 404 "Acute Dermal Irritation/Corrosion" and Method B4 of Comnission Directive 92/69/EEC. A single 4hr, semi-occluded application of 1272W94 to the intact skin of three rabbits produced very slight to well defimed erythema and very slight oedema. All treated skin appeared normal within the 48hrs observation period. The Primary Irritation Index of was 0.3 and 1272W94 was classified a mild irritant to rabbit skin according to the Draize classification scheme.