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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
17th July to 7th August 2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106))

Test material

Constituent 1
Chemical structure
Reference substance name:
(1R, 4R, 5S) 4-hydroxy-6,6-dimethyl-3-Oxabicyclo[3.1.0]hexan-2-one
EC Number:
619-753-7
Cas Number:
73611-02-6
Molecular formula:
C7H10O3
IUPAC Name:
(1R, 4R, 5S) 4-hydroxy-6,6-dimethyl-3-Oxabicyclo[3.1.0]hexan-2-one

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye remained untreated and was used for control purposes
Duration of treatment / exposure:
A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye.
Observation period (in vivo):
1 hour
24 hours
48 hours
72 hours
7 days
14 days
21 days
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
of 1
Time point:
other: 24 hours
Score:
16
Max. score:
16
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Petechial haemorrhage on the nictitating membrane
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
of 1
Time point:
other: 72 hours
Score:
12
Max. score:
16
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Haemorrhage in nictitating membrane 2 mm x 2 mm
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
of 1
Time point:
other: 14 days
Score:
0
Max. score:
16
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
of 1
Time point:
other: 48 hours
Score:
40
Max. score:
40
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: vascuralisation of the cornea at 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
of 1
Time point:
other: 7 days
Score:
20
Max. score:
40
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: vascuralisation of the cornea at 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced irriversible ocular damage and was considered to be corrosive to the rabbit eye (based on one rabbit only)