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
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD method, CLP compliance
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Magnusson & Kligman OECD Guideline 406 (1981) EEC Directive 84/449 (1984)Annex V - Method B6
GLP compliance:
yes
Type of study:
other: not provided
Test material information:
Composition 1
Species:
other: Albino Hartley Guinea-pig
Concentration / amount:
Concentration of test material and vehicle used at induction:
Test article in a 0.1 % (WIW) suspension in abs. ethanol.

Concentration of test material and vehicle used for each challenge:

Test article in a 50 % (W/W) paste in absolute ethanol.
Concentration / amount:
Concentration of test material and vehicle used at induction:
Test article in a 0.1 % (WIW) suspension in abs. ethanol.

Concentration of test material and vehicle used for each challenge:

Test article in a 50 % (W/W) paste in absolute ethanol.
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 group
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 group
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:
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:
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.

Maximum concentration not causing irritating effects in preliminary test:50%

Signs of irritation during induction: Yes

Evidence of sensitisation of each challenge concentration: None

Other observations: /

Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two skin sensitisation studies in the guinea pig (guinea pig maximisation test, GPMT) were available. In the supporting study (Annex V, GLP), the substance was tested using 0.5% in arachnis oil B.P. (intradermal) and 25% in arachnis oil B.P. (topical) for induction and 10%/5% in arachnis oil B.P. for challenge. No positive response was observed upon challenge in test or control animals.

The study chosen as a key study was a GPMT conducted according to OECD 406/GLP. The maximum concentration not causing irritating effects in a preliminary test was 50%. In the main study, adult guinea pigs (Albino Hartley; 20 test animals per dose, 10 control animals) were induced by applications of 0.1 % (w/w) suspension of the test substance in absolute ethanol and challenged with 50 % (w/w) paste in absolute ethanol. Animals were observed for a response at 24hrs and 48hrs. There were signs of irritation during induction. No positive response was observed upon challenge in test or control 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:
Not sensitising (Annex V, GPMT; GLP)

Justification for selection of skin sensitisation endpoint:
Only 1 key study available.

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 Flyadd-3 (CAS No. 135861-56-2) does not need to be classified for skin sensitisation when considering the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC) and Annex I of Regulation 286/2011/EC.