(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate

Endpoint summary

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.