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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Skin Irritation/Corrosion: not irritating (EPA-guideline 798.4470 (based on Directive 92/69/EEC,B.3)/GLP)

Serious eye damage/eye irritation: not irritating (EPA-guideline 798.4500 (based on Directive 92/69/EEC,B.5)/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: GLP Compliance, not OECD guideline
Qualifier:
according to guideline
Guideline:
other: EPA-guideline 798.4470 (based on Directive 92/69/EEC,B.3)
GLP compliance:
yes
Species:
other: Rabbit, NEW ZEALAND WHITE
Type of coverage:
semiocclusive
Vehicle:
other: The material was wetted with 0.5 ml deionized water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
other: Not specified
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
other: Not specified
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0
Other effects:
Only very slight erythema was observed in one animal at the 30 to 60 minute inetrval. The other animals showed no dermal effects.
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: GLP Compliance, not OECD guideline
Qualifier:
according to guideline
Guideline:
other: EPA-guideline 798.4500 (based on Directive 92/69/EEC,B.5)
GLP compliance:
yes
Species:
other: Rabbit NEW ZEALAND WHITE
Amount / concentration applied:
80 mg
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.61
Max. score:
2
Remarks on result:
other: Max. duration: 2 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
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

There are no in vitro skin irritation/corrosion studies available. There is one in vivo study in rabbits available.

In a primary dermal irritation study (EPA-guideline 798.4470 (based on Directive 92/69/EEC,B.3)/GLP), 6 New Zealand white rabbits were dermally exposed (semi-occlusive) to 0.5g of 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane wetted with 0.5 ml deionized water for 4 hours. Only very slight erythema was observed in one animal at the 30 to 60 minute interval. The other animals showed no dermal effects.

Eye irritation

There are no in vitro eye irritation studies available. There is one in vivo study in rabbits available.

In a primary eye irritation study (EPA-guideline 798.4500 (based on Directive 92/69/EEC,B.5)/GLP), 80 mg of 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane was instilled into the eye of 6 New Zealand white rabbits. The mean conjunctivae score (redness) was 0.61 (max score: 2) for 2 hrs maximum. All other parameters (chemosis, cornea, iris score) were 0. All observed effects were reversible within 7 days.

The studies are suitable to use in the human health risk assessment.

Justification for classification or non-classification

 Based on the available information in the dossier, the substance 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane (CAS: 154862-43-8) does not need to be classified for skin irritation/corrosion and serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC are applied.