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Diss Factsheets

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Skin sensitisation (in vitro): Waived

Skin sensitisation (in vivo): Not sensitising (Directive 92/69 EEC, B.6 maximization test/GLP)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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: Directive 92/69 EEC, B.6 maximization test
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study (GPMT) was provided in the inquiry data.
Species:
other: Giunea pig, HIMALYAN
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group:10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Not specified
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

Maximum concentration not causing irritating effects in preliminary test: 50 % Signs of irritation during induction: Neither erythema nor oedema were observed in the animals of the test group and the control group after the intradermal and epidermal induction. Evidence of sensitisation of each challenge concentration: 50% : 0/20 of the animals showed sensitization

Interpretation of results:
other: not classified
Executive summary:

In a in vivo skin sensitization study with 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) in vehicle (1:1 mixture of FCA/physiological saline; 5% test substance diluted in ethanol; 5% test substance emulsified in a 1:1 mixture of FCA/physiological saline), 20 Himalayan guinea pigs were tested in a maximisation test. 0/20 of the animals showed positive skin reactions, so the substance is not sensitising.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation (in vivo):

There is no in vitro skin sensitisation data available. There is one in vivo guinea pig maximisation test available.

In a dermal sensitization study (Directive 92/69 EEC, B.6 maximization test/GLP) with 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane in ethanol, Himalayan guinea pigs were tested in a maximisation test. For induction, 5% of the test item in ethanol (intradermal application) and 50% of the test item in ethanol (epidermal application) was used. For challenge, 50% of the test item in ethanol was used for epidermal application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. Neither erythema nor oedema were observed in the animals of the test group and the control group after the intradermal and epidermal induction. 0/20 of the test item animals showed positive skin reactions and 0/10 of the control animals showed positive skin reactions. Based on these results, the substance is not sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 No. 154862-43-8) does not need to be classified for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.