Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin Sensitisation: The test substance was not sensitising to the skin of guinea pigs in a guinea pig maximisation test. [EU Method B.6, GLP]

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Use of data >12 years received after successful inquiry, no new study has been conducted.
Species:
guinea pig
Strain:
Himalayan
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
Induction lntradermal: 0.1 mL
1) solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% test substance in solution CFA: physiological saline (50: 50)
Induction epidermale:
75% tets substance in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
Induction lntradermal: 0.1 mL
1) solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% test substance in solution CFA: physiological saline (50: 50)
Induction epidermale:
75% tets substance in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 %
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 %
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
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: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
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: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
other: not specified

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

No signs of irritation during induction, no evidence of sensitisation of each challenge concentration. Further, no mortality and no clinical signs or body weight changes have been observerd during the test.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be not sensitising under the conditions of the test.
Executive summary:

The test substance was tested to be not sensitising to the skin of guinea pigs in a GLP study according to EU Method B.6.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The sensitising potential of the test substance has been determined in a GLP compliant test with guinea pigs according to EU Method B.6. In this study the test substance was not sensitising to the skin of guinea pigs and does therefore not need to be classified according to Regulation 1272/2008/EC.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation

According to the European regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification and will not require labelling as sensitising to the skin.

Categories Display