Registration Dossier

Administrative data

Description of key information

Skin irritation:
The test substance is not a skin irritant.
Eye irritation:
The test substance is not an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg


Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
SCORING SYSTEM:
Immediately following removal of the semi-occlusive patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.

Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observation
Irritant / corrosive response data:
No irritation was observed at any time point and all scores for erytheam and edema were 0 after 72 hours.
Other effects:
None (no signs of toxicity).
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not a skin irritant and should not be classified as a skin irritant.
Executive summary:

Skin irritation

The test substance was assessed for skin irritation according to EU Method B4. 

No irritation was observed after a 4 hour exposure in any animal, at any time point and all scores for erythema and edema were 0 after 72 hours.No signs of toxicity were noted either.

The substance is not a skin irritant.

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 45 mg
Duration of treatment / exposure:
Single application for 72 hour exposure.
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize scale for scoring ocular irritation.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: maximum score for all animals
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 day
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No chemosis observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No chemosis observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No chemosis observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No corneal effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 1)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 2)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 3)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects observed
Irritant / corrosive response data:
No chemosis, corneal or iridial effects were noted during the study.
Minimal conjunctival irritation (redness, score of 1) was observed in animals after 1 hour. These effects were fully reversible within 1 day.
Other effects:
None.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an eye irritant and should not be classified as an eye irritant.
Executive summary:

Eye irritation

The test substance was assessed for eye irritation according to EU Method B5. 

No chemosis, corneal or iridial effects were noted during the study. Minimal conjunctival irritation (redness, score of 1) was observed in animals after 1 hour. These effects were fully reversible within 1 day.

The substance is not an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The test substance was assessed for skin irritation according to EU Method B4. 

No irritation was observed after a 4 hour exposure in any animal, at any time point and all scores for erythema and edema were 0 after

72 hours.No signs of toxicity were noted either.

The substance is not a skin irritant.

Eye irritation

The test substance was assessed for eye irritation according to EU Method B5. 

No chemosis, corneal or iridial effects were noted during the study. Minimal conjunctival irritation (redness, score of 1) was observed in animals after 1 hour. These effects were fully reversible within 1 day.

The substance is not an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for use for the substance being registered.
Study conducted in accordance with generally accepted scientific principles and guidelines.

Justification for selection of eye irritation endpoint:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for use for the substance being registered.
Study conducted in accordance with generally accepted scientific principles and guidelines.

Justification for classification or non-classification

The results from skin irritation and eye irritation studies were evaluated according to the Classification, Labelling and Packaging Regulation (EC) 1272/2008 (CLP).

Skin irritation:

No skin irritation was caused by 4 hours exposure to the test substance. Based on these results, the substance does not have to be classified as a skin irritant as it does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP).

Eye irritation:

No chemosis, corneal or iridial effects were noted during the study. Minimal conjunctival irritation (redness, score of 1) was observed in animals after 1 hour. These effects were fully reversible within 1 day.

The overall results calculated on the basis of the scores for each animals at 24, 48 and 72 hours did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP). The test substance is therefore not classified for eye irritation.