Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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