Registration Dossier

Administrative data

Description of key information

Skin Irritation/Corrosion: Not Irritating (New Zealand White Rabbit)
Eye Irritation: Not Irritating (New Zealand White Rabbit)

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
Study period:
Details not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Details not available
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: Distilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
Not specified
Number of animals:
3
Details on study design:
Details not available
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: overall at 24, 48 & 72h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: overall at 24, 48 & 72h
Score:
0
Irritant / corrosive response data:
Not specified
Other effects:
Not specified
Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: not specified
Conclusions:
Not irritating
Executive summary:

The skin irritation/corrosion was measured using the OECD 404 and EU B4 test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. The test substance is not irritating.     

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
Study period:
Details not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Details not available
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
65 mg
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
Not specified
Number of animals or in vitro replicates:
3
Details on study design:
Details not available
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: overall at 24h, 48h & 72h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Max. duration: 48h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24h, 48h & 72h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Max. duration: 48h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24h, 48h & 72h
Score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24h, 48h & 72h
Score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversilibity of any observed effect: Changes fully reversible within 2 days.
Other effects:
All three animals gave a "positive" response. Transient, mild conjunctival irritation only was observed.The eyes wer normal 2 days after instillation.
Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: not specified
Conclusions:
Not irritating.
Executive summary:

The eye irritation was determined using the OECD 405 and EU B5 test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. The test substance is not irritating.     

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

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.

Justification for selection of eye irritation endpoint:
Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.

Justification for classification or non-classification

The substance is not classified under CLP as it does not fill the requirements for skin irritation/corrosion or eye irritation classification.