Registration Dossier

Administrative data

Description of key information

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study-GLP compliance
Qualifier:
according to
Guideline:
other: Method B6 of 92/69/EEC or OECD 406
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
other: guinea pig, albino Dunkin-Hartley
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction:

FCA in distilled water (1:1)

5% w/v formulation of test material in arachis oil

5% w/v formulation of test material in 1:1 preparation of FCA in distilled water

Topical induction:

75% w/v in arachis oil

Concentration of test material and vehicle used for each challenge:
50% and 75% w/v in arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction:

FCA in distilled water (1:1)

5% w/v formulation of test material in arachis oil

5% w/v formulation of test material in 1:1 preparation of FCA in distilled water

Topical induction:

75% w/v in arachis oil

Concentration of test material and vehicle used for each challenge:
50% and 75% w/v in arachis oil
No. of animals per dose:
10 animals in test group
5 animals in negative control group
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. 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:
5
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: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 75 %

Signs of irritation during induction:

Very slight (3 animals) to moderate to severe erythema (7 animals) was noted after the intradermal induction at the 24 hour reading, and very slight to severe erythema after 48 hours.

After topical induction, very slight erythema was observed in all test animals and very slight oedema was noted in 4 test group animals at the 1 -hour reading. No dermal reactions were noted after 24 hours.

Evidence of sensitisation of each challenge concentration: No sensitisation observed.

Other observations:

One test animal was killed for humane reasons on day 16. Its absence was not considered to affect the purpose or integrity of the study.

Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
The substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) was tested in 3 skin sensitisation tests. A guideline Buehler test using 100% undiluted substance for induction produced no reaction. The study chosen as a key study was a Guinea Pig Maximisation Test (GPMT) conducted according to guideline OECD 406/GLP. Adult guinea pigs (albino Dunkin-Hartley; 10 test animals per dose, 5 control animals) were induced by applications of the test substance, 5% (w/v) in arachis oil in 1:1 preparation of FCA (intradermal application) and 75% in arachis oil (topical application). After being challenged with 50% and 75% w/v in arachis oil, animals were observed for a response at 24h and 48h. No positive response was observed to the concentrations tested in any of the animals. These results indicate a sensitization rate of 0%. The substance can be classified as non-sensitising in albino guinea pigs.

Migrated from Short description of key information:
Skin sensitisation: Not sensitising (OECD 406, Guinea pig maximisation test; GLP)

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
This information is not available

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 sensitisation when considering the criteria outlined in Annex I of 1272/2008/EC.