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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

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
Details on test material:
Nature of substance: Colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
MG
Duration of treatment / exposure:
up to 72hrs
Observation period (in vivo):
Observations made 1, 3, 6, 24, 48 , 72hrs and 7 days after instillation of the test material
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
>= 2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72hrs
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
Instillation into the eye caused moderate initial pain in
the first animal treated and the eyes of the other two
animals were pre-treated with a local anaesthetic.


Dulling of the normal lustre of the corneal surface was
noted in one animal for six hours after instillation of the
test substance.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize
Conclusions:
A study was performed to assess the irritancy potential of 1272W94 to the eye of the New Zealand White rabbit using the method descibed in OECD No 405 " Acute Eye Irriation/Corrosion". 0.1ml of 1272W94 produced a maximum Overall Mean Score of 15.3 and was classified as a slight irritant (grade 2) to the rabbit eye according to the Draize classification scheme. 1272 W94 did not meet the criteria for classification as irritant to eyes according to EC labelling Regulations.
Executive summary:

A study was performed to assess the irritancy potential of 1272W94 to the eye of the New Zealand White rabbit using the method descibed in OECD No 405 " Acute Eye Irriation/Corrosion". A single 0.01mL application of the test material to the non-irrigated eye of one rabbit produced no occular effects. A single application of 0.1mL to the non-irrrigated eyes of 3 rabbits produced a slight corneal, mild iridial and slight conjunctival reaction. Treated eyes appeared normal at the 72 h or 7 day observations.0.1ml of 1272W94 produced a maximum Overall Mean Score of 15.3 and was classified as a slight irritant (grade 2) to the rabbit eye according to the Draize classification scheme.