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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975
Reference Type:
other: OECD SIDS
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guidelines
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: yellow crystals

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- Diet: Mischfutter ERKA 8300 der Futtermittelwerke Robert Koch oHG/ Hamm, ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
other: sesame oil or unchanged (no vehicle)
Controls:
other: untreated eye served as a negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (undiluted) or 0.1 mL (10% dilution)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
one instillation
Observation period (in vivo):
up to 24 hours
Number of animals or in vitro replicates:
6
Details on study design:
- Washing (if done): fluorescein instillation at 24 hours, followed by iggrigation with physiological NaCl solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: undiluted
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
2
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 3, 5, 6
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 4
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 4
Time point:
other: 7 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 3, 5, 6
Time point:
other: 7
Score:
0
Max. score:
3
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
3
Remarks on result:
other: undiluted
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: undiluted
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: 10% solution
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
2
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
animal: 3, 4, 6
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 h
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 2, 5
Time point:
other: 7 h
Score:
0
Max. score:
3
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7, 24 h
Score:
0
Max. score:
3
Remarks on result:
other: 10% solution
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: 10% solution
Irritant / corrosive response data:
Slight to moderate redness of conjunctivae was observed in all animals 1 hour post-instillation. At 7 hours observation, 2 out of 6 rabbits still had slight redness of conjunctivae, which was fully resolved at 24 hours observation point.
No other effects were noted.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information