Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August-October 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch no: 910312 (see CoA attached)
Purity: 88±3% (m/m)
Other: mono-citracon-mono-itaconimide isomer: 6.5±2% (m/m)
unknown: 5.5±2% (m/m)

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Concentration of test material and vehicle used at induction:
First induction (intradermal):
0.1 % w/v in propyleneglycol 0.1 % w/v in propyleneglycol in FCA
Second induction (topical): 10% w/v in propyleneglycol
Concentration of test material and vehicle used for each challenge: 3 % w/v in propyleneglycol 0.3 % w/v in propyleneglycol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Concentration of test material and vehicle used at induction:
First induction (intradermal):
0.1 % w/v in propyleneglycol 0.1 % w/v in propyleneglycol in FCA
Second induction (topical): 10% w/v in propyleneglycol
Concentration of test material and vehicle used for each challenge: 3 % w/v in propyleneglycol 0.3 % w/v in propyleneglycol
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Challenge controls:
Yes
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
3 %
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 17.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
.3 %
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .3 %. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
3 %
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 18.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
.3 %
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .3 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
.3 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: .3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
.3 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: .3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction: Intradermal induction gave rise to barely-perceptible to moderate erythema, pallor and discolouration
Topical induction gave rise to barely perceptible or slight erythema, but eschar formation and exfoliation.
Evidence of sensitisation of each challenge concentration: A significant respons was observed in 19 test and one control animal.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Because 19 out of 20 animals showed a dermal response following challenge, versus one control animal, the test substance was considered a dermal sensitiser.