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Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This information is not provided in the migrated NONS file provided by ECHA.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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.
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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).