Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin Irritation/Corrosion : not irritating  (OECD 404, GLP) 
Eye irritation: not irritating (OECD 405, 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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study-GLP compliance
Qualifier:
according to guideline
Guideline:
other: Method B4 of 92/69/EEC and OECD 404
GLP compliance:
yes
Species:
other: Rabbit (New Zealand White)
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: None
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24h, 48h and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24h, 48h and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24h, 48h and 72h
Score:
0
Irritation parameter:
erythema score
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 24h, 48h and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean value 2)
Time point:
other: overall at 24h, 48h and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean value 3)
Time point:
other: overall at 24h, 48h and 72h
Score:
0
Irritation parameter:
edema score
Score:
0
Remarks on result:
other: Max duration: 0 d; Max value at end of observation period: 0 (Related to all animals)
Other effects:
None
Interpretation of results:
not classified
Remarks:
Migrated information
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study-GLP compliance
Qualifier:
according to guideline
Guideline:
other: Method B5 of directive 92/69/EEC or OECD 405
GLP compliance:
yes
Species:
other: Rabbit (New Zealand White)
Amount / concentration applied:
0.1 mL
Number of animals or in vitro replicates:
3 animals
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max duration: 1 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 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max duration: 0 h; Max 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 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max duration: 0 h; Max value at end of observation period: 0 (Related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max duration: 0 h; Max value at end of observation period: 0 (Related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
None
Interpretation of results:
not classified
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/Corrosion                                                                                        

Three skin irritation/corrosion in vivo guideline studies carried out in the rabbit were available. A supporting study in 6 animals (occlusive) showed no irritation and another supporting study in 6 animals (semi-occlusive) showed a barely perceptible erythema score (1) that was fully reversible after 4 days. The key study was carried out in accordance with OECD 404/GLP in 3 animals with 0.5 mg of substance applied for 4 hours (semi-occlusive) and showed no irritation.

Based on an in vivo skin irritation/corrosion test (OECD 404) conducted in accordance with GLP, the substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No.5945-33-5) is not irritating to the skin.

Eye irritation                                                                                                              

Three eye irritation in vivo guideline studies carried out in the rabbit were available. A supporting study in 6 animals showed no signs of any ocular lesions while another supporting study in 3 animals showed conjunctival redness (mean score of 1) which was fully reversible and chemosis (mean score:1) which resolved within 24 hours The key study was carried out in accordance with OECD 405/GLP in 3 animals with 0.1 mL test substance which showed conjunctival redness (mean score of 1) which resolved within 1 hour.

Based on an in vivo eye irritation test (OECD 405) conducted in accordance with GLP, the substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No.5945-33-5) is not irritating to the eye.

Justification for classification or non-classification

Based on the available information in the dossier, the substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No.5945-33-5) does not need to be classified for skin irritation/corrosion or eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.