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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-propynyl butylcarbamate
EC Number:
616-291-8
Cas Number:
76114-73-3
Molecular formula:
C8H13NO2
IUPAC Name:
2-propynyl butylcarbamate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test item/animal)
Topical induction: 100 % (= 500 mg test item/animal)
Challenge: 100 % (= 500 mg test item/animal)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test item/animal)
Topical induction: 100 % (= 500 mg test item/animal)
Challenge: 100 % (= 500 mg test item/animal)
No. of animals per dose:
No of animals in test group: 10 animals
No of animals in negative control group:5 animals

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
red wheal, encrustation, white wheal with red surrounding, white wheal encrustation (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.)
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: red wheal, encrustation, white wheal with red surrounding, white wheal encrustation (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.).
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
red wheal, encrustation, white wheal with red surrounding (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.)
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: red wheal, encrustation, white wheal with red surrounding (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.).
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information