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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data originally submitted as part of the 67/548/EEC notification package.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
2.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
2.3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
chemosis score
Max. score:
3
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
cornea opacity score
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; 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 14 days
Other effects:
A single application of the test substance to the non- irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation and the remaining treated eye appeared normal at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single application of the test substance to the non-irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation and the remaining treated eye appeared normal at the 14-day observation.
Executive summary:

A single application of the test substance to the non-irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation

and the remaining treated eye appeared normal at the 14-day observation.

The substance is not classified.