Registration Dossier

Administrative data

Description of key information

No effects of skin corrosion and irritation have been observed.
No adverse effects on eye damage or irritation have been observed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Remarks:
The test material as supplied was moistened with 0.5 ml of distilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
no data
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Max. score:
0
Reversibility:
no data
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Max. score:
0
Reversibility:
no data
Remarks on result:
other: Max duration: d; Max. value at end of observation period (related to all animals)
Other effects:
Grade 1 erythema observed in 2 animals at 1 animal only
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
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: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
41 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible
Remarks:
3 days
Irritation parameter:
iris score
Basis:
mean
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: h; Max. value at end of observation period:(related to all animals)
Other effects:
Conjunctival redness and chemosis were observed at 1 hour reading (mx grade 2)
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two "in-vivo" studies are available for each endpoint skin irritation and eye irritation.

Skin irritation

The two studies for skin irritation/corrsosion were performed according EU Test Method B4 and/or OECD Guideline 404. The animals tested where rabbits (New Zealand White, and New Zealand hybrid albino) and were exposed for 4 hours to the substance. Erythema and edema were recorded after 24, 48 and 72 hours after exposure of 500 mg in one of the tests, and after 48 days after exposure of 46 mg in the other test.

Exposure to 500 mg gave a mean score of 0 in each case. Exposure to 46 mg gave erythema score max. 2, but the effects were fully reversible after 3 days.

The results are considered valid for classification and labelling and hazard assessment.

Eye irritation

The two studies for eye irritation were performed according EU Test Method B5 and/or OECD Guideline 405. The animals tested where rabbits (New Zealand White, and New Zealand hybrid albino) treated with 20 mg of substance in one of the tests and with 41 mg in the other test. There were observed a few effects which were fully reversible after 3 days (for test with 41 mg) and after 7 days (for test with 20 mg).

The results are considered valid for classification and labelling and hazard assessment.


Justification for selection of skin irritation / corrosion endpoint:
There are two test results available, with same results.

Justification for selection of eye irritation endpoint:
There are two test results available, with same results.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The values obtained have been compared to criteria set up in the Annex I of the Regulation (section 3.2 for skin irritation and section 3.3. for eye irritation). As a result the substance is not considered to be classified as skin irritant under Regulation (EC) No. 1272/2008.

As a result the substance is not considered to be classified as eye irritant under Regulation (EC) No. 1272/2008.