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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Lack on details of test substance. However details were achieved from the sponsor.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
73296-89-6 (purity 30%)
IUPAC Name:
73296-89-6 (purity 30%)
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: Opaque white liquid
- Analytical purity: 30% a.i.
- Lot/batch No.: TGD010.0080
- Storage condition of test material: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
According to Guideline.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
21 days
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+72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0.2
Max. score:
2
Reversibility:
not fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
2.8
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
3.6
Max. score:
4
Reversibility:
fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information R41 Criteria used for interpretation of results: EU