Registration Dossier

Administrative data

Description of key information

Skin Irritation/Corrosion: not irritating (Annex V; GLP)
Serious eye damage/eye irritation: not irritating (Annex V; GLP)

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test material information:
Composition 1
Species:
other: Rabbit (New Zealand White)
Type of coverage:
semiocclusive
Vehicle:
other: The test material as supplied was moistened with 0.5 ml of distilled water.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
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
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Max. score:
0
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 hour only.
Interpretation of results:
other: not classified
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test material information:
Composition 1
Species:
other: Rabbit (New Zealand White)
Amount / concentration applied:
41 MG
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
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
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; rvJax. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
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
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Conjunctival redness and chemosis were observed at 1 hour
reading (max grade 2)
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/Corrosion

Two skin irritation in vivo studies carried out in the rabbit were available. In the supporting study (OECD 404, GLP), 6 rabbits were dermally exposed (semi-occlusive) to 46 mg of the test substance in liquid paraffin for 4 hrs. Erythema (max score: 2, reversible within 3 days) was indicated and no odema.

In the primary dermal irritation key study (Annex V/ GLP), 3 rabbits (New Zealand White) were dermally exposed (semi-occlusive) to 0.5g of the test substance moistened with water for 4 hrs. Grade 1 erythema was observed in 2 animals at 1 hour only. The substance was considered non-irritating in the in vivo skin irritation/corrosion test.

Serious eye damage/eye irritation

Two eye irritation in vivo studies carried out in the rabbit were available. In the supporting study (OECD 405, GLP), 6 rabbits were exposed to 20 mg of the test substance. The following effects were noted: conjunctival redness (max score: 2; max. duration: 72hrs); chemosis (max score: 2; max. duration: 24hrs); cornea (max score: 1; max. duration: 24hrs); iris (max score: 1; max. duration: 24hrs). The changes were fully reversible within 7 days.

In a primary eye irritation key study (Annex V/GLP), 41 mg test substance was instilled into the eye of 3 rabbits (New Zealand White). The following effects were noted: conjunctival redness (max score: 1; max. duration: 48hrs); chemosis (max score: 1; max. duration: 24hrs). Conjunctival redness and chemosis were observed at 1 hour reading (max score 2) and all observed effects were fully reversible within 3 days. The substance was considered non-irritating in the in vivo eye irritation test when compared to the classification criteria in the CLP Regulation.


Justification for selection of skin irritation / corrosion endpoint:
According to OECD 404 (Acute Dermal Irritation/Corrosion), a dose of 0.5 g of solid or paste is applied to the test site. In the key study the amount of substance applied was 0.5g while in the supporting study the amount of substance applied was 46mg. The key study was selected as it adhered more closely to the current OECD guideline

Justification for selection of eye irritation endpoint:
According to OECD 405 (Acute eye irritation/corrosion), the maximum amount of solid substance that may be applied is 100mg. In the key study the amount of substance applied was 41mg while in the supporting study the amount of substance applied was 20mg. The key study was selected as it adhered more closely to the current OECD guideline.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Flyadd-3 (CAS No. 135861-56-2) does not need to be classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.