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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
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 or test system 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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
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.