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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Qualifier:
according to guideline
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
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 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:
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.