Registration Dossier

Administrative data

Description of key information

Skin Irritation: The skin irritation potential of the test item was determined. Skin irritating effects were observed. 
Eye Irritation: According to the ECHA disseminated dossier the substance causes serious eye damage.

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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)
Qualifier:
no guideline followed
Principles of method if other than guideline:
Evaluation of the skin irritation potential following repeated application (open, semiocclusive and occlusive) to rabbit skin.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
other: open, semiocclusive and occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Irritation parameter:
other: general skin irritation
Time point:
other: unknown
Reversibility:
no data
Remarks on result:
other: No scores reported, observations made following repeated application: no irritation (uncovered skin), redness and exfoliation (semiocclusive), severe necrosis (occlusive).
Irritant / corrosive response data:
When the test substance was applied repeatedly to the uncovered skin of the rabbit it did not cause irritation but if the skin was covered with a cloth, redness and exfoliation resulted. Confinement of the material under an impervious covering resulted in severe necrosis.
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential of the test item was determined. Skin irritating effects were observed.
Executive summary:

The skin irritation potential of the test item was determined. The test substance was applied repeatedly to the uncovered skin of the rabbit. The type of coverage was open, semiocclusive and occlusive. Skin irritating effects were observed. If the skin was covered with a cloth, redness and exfoliation were observed. Confinement of the material under an impervious covering resulted in severe necrosis. No scores were reported.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)
Principles of method if other than guideline:
Method: other: instillation of the undiluted test item into the rabbit eye.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
not specified
Irritant / corrosive response data:
Irritating
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential of the test item was determined. Irritating effects were observed.
Executive summary:

The eye irritation potential of the test item was determined by instillation of the undiluted test item into the rabbit eye. Irritating effects were observed during the study. No further information are given.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritation potential of the test item was determined. The test substance was applied repeatedly to the uncovered skin of the rabbit. The type of coverage was open, semiocclusive and occlusive. Skin irritating effects were observed. If the skin was covered with a cloth, redness and exfoliation were observed. Confinement of the material under an impervious covering resulted in severe necrosis. No scores were reported.

Eye irritation

The eye irritation potential of the test item was determined by instillation of the undiluted test item into the rabbit eye. Irritating effects were observed during the study. No further information are given.

According to the ECHA disseminated dossier the following effects were determined:

Conjunctivae:

Animal 1: 2 (24, 48, 120h)

Animal 2: 1 (24, 48, 120h)

Animal 3: 2.33 (24, 48, 120h)

Animal 4: 2.67 (24, 48, 120h)

Chemosis:

Animal 1: 1.33 (24, 48, 120h)

Animal 2: 2.33 (24, 48, 120h)

Animal 3: 1 (24, 48, 120h)

Animal 4: 0 (24, 48, 120h)

Cornea

Animal 1: 3 (24, 48, 120h)

Animal 2: 1.67 (24, 48, 120h)

Animal 3: 2.33 (24, 48, 120h)

Animal 4: 3 (24, 48, 120h)

Iris

Animal 1: 0.67 (24, 48, 120h)

Animal 2: 0 (24, 48, 120h)

Animal 3: 0.67 (24, 48, 120h)

Animal 4: 0 (24, 48, 120h)

Conclusion:

Eye irritating effects were found in 4 animals. Some effects were not reversible after a observation period of 8 days.


Justification for selection of skin irritation / corrosion endpoint:
only secondary literature (handbook)

Justification for selection of eye irritation endpoint:
According to ECHA disseminated dossier the substance is classified as eye dam. 1

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation according to Annex VI of Regulation (EC) 1272/2008
According to the harmonised Annex VI classification the substance is considered to be classified for skin irritation cat. 2 H315 under Regulation (EC) No 1272/2008.

Self-Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the test substance is considered to be classified as skin irritating cat. 2 H315 and as eye irritating cat. 1 H318 under Regulation (EC) No 1272/2008.