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: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No date
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
other: 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.
Route:
other: epicutaneous, nut no details on either it was occlusive or semi-occlusive dressings
Vehicle:
other: 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 study: 50%

Signs of irritation during induction: yes

Evidence of sensitisation of each challenge concentration: none

No more information is available in the migrated NONS file provided by ECHA.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article has been determined not to be a dermal sensitiser.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this data is not owned by the registrant.

The test item appeared not to be a sensitiser when tested under OECD Guideline 406 (1981). As a consequence, the test material do not fullfill the classification criteria for skin sensitisation according to DSD (67/548/EEC) or CLP (1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
two different studies OECD406 on guinea pig where performed with two different vehicle (absolute ethanol or arachis oil). The results indicated no sensitisation effect with the test substance.

Justification for selection of skin sensitisation endpoint:
report on test substance provided by ECHA using 12 year rule

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test material was tested according to the OECD Guideline 406 on guine pigs in two studies. The substance do not fulfill the classification criteria for skin sensitisation according to DSD (67/548/EEC) or CLP (1272/2008).