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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: 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 and GLP compliant study
Qualifier:
according to guideline
Guideline:
other: Based on the recommendations of the OECD Guideline for the Testing of Chemicals No. 406 (Magnussen and Kligman method)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
other: guinea pig, Albino Dunkin-Hartley
Route:
intradermal and epicutaneous
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal injection: 0.25% (w/w) in acetone, 5% (v/v) in Alembicol D

0.25% (w/w) in a mixture of Freund's Complete Adjuvant and acetone, 5% v/v in Alembicol D.

b) Topical induction: 50% (w/w) in acetone.


Concentration of test material and vehicle used for each challenge:

a) 50% (w/w) in acetone
b) 20% (w.w) in acetone
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal injection: 0.25% (w/w) in acetone, 5% (v/v) in Alembicol D

0.25% (w/w) in a mixture of Freund's Complete Adjuvant and acetone, 5% v/v in Alembicol D.

b) Topical induction: 50% (w/w) in acetone.


Concentration of test material and vehicle used for each challenge:

a) 50% (w/w) in acetone
b) 20% (w.w) in acetone
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:
8
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: 8.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
9
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: 9.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
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: 20%. 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:
5
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: 5.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
6
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: 6.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 2.0. Total no. in groups: 10.0.

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

Signs of irritation during induction:

Dermal reactions in test animals were similar to or less than the maximum reaction seen in control group animals.

Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of sensitisation at each challenge concentration: 0/20.

Other observations:

Bodyweight gains of animals in the test group, between day 0 and day 24, were comparable to those in the control group.

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

The substance was tested in 3 skin sensitisation tests. 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; 20 test animals in test group, 10 animals in control group) were induced by applications of the test substance, 0.25% w/w in acetone(test)/0.25% FCA and acetone(vehicle), 5% in alembicol (intradermal application) and 50% in acetone (topical application). The concentration of test material and vehicle used for each challenge was 50% and 20% w/w/ in acetone.Dermal reactions were seen in test animals after challenge were considered to be comparable to those seen in control animals and were therefore not due to sensitisation.


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

Justification for selection of skin sensitisation endpoint:
OECD Guideline and GLP compliant study

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 bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) does not need to be classified for skin sensitisation when considering the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.