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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliance and OECD method
Qualifier:
according to
Guideline:
other: 84/449/ewg,b.6(Meerschweinchen-Maximlerungstest(GPMT));OECD 406
GLP compliance:
yes
Species:
other: gpg, Pltbright White Tif:DHP
Concentration / amount:
Concentration of test material and vehicle used at induction:
a)Intradermal: 5% In Arachisoil
b)Dermal:30% i Vaseline
Concentration of test material and vehicle used for each challenge;
10% in Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
a)Intradermal: 5% In Arachisoil
b)Dermal:30% i Vaseline
Concentration of test material and vehicle used for each challenge;
10% in Vaseline
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:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Maximum concentration not causing irritating effects in preliminary test:30%

Signs of irritation during induction:

None other than effects normally observed.

Evidence of sensitisation of each challenge concentration: 0/20

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification