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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

No irritation noted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex 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.
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.4
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation / corrosion parameter:
other: erythema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #1 (mean score 1). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: erythema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #2 (mean score 2). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: erythema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #3 (mean score 3). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: erythema score
Remarks on result:
other:
Remarks:
Max. score: 0.0. Remarks: Max. duration: d; Max. value at end of observation period: 0 (related to all animals). (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #1 (mean score 1). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #2 (mean score 2). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
0
Remarks on result:
other:
Remarks:
Basis: animal #3 (mean score 3). Time point: overall at 24, 48 and 72 h. (migrated information)
Irritation / corrosion parameter:
other: edema score
Remarks on result:
other:
Remarks:
Max. score: 0.0. Remarks: Max. duration: d; Max. value at end of observation period: 0 (related to all animals). (migrated information)
Interpretation of results:
not classified
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation.

No effects were noted. The substance is not classified.
Executive summary:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation.

No effects were noted. The substance is not classified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation.

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation. No effects were noted. The substance is not classified.

Eye irritation. 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.


Justification for selection of skin irritation / corrosion endpoint:
GLP study

Justification for selection of eye irritation endpoint:
GLP study

Justification for classification or non-classification

No effects noted in in vivo studies.