Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test substance was standard quality material EC No 415-890-1 HPLC assay >98%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Thirty female albino guinea pigs with weight range 299 to 364 g and approx age 6 to 7 weeks were aclimatised to the experimental conditionsfor thirteen days prior to the allocation to the main study. An additional 6 animals of the same starin and supplier were used for preliminary investigations. the animall on the main study were allocated into two groups 10 to control group and 20 to Test group.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
coconut oil
Concentration / amount:
Intradermal: 7.5% in 5% acetone in Coconut oil: Topical application 60% weight in acetone: Challenge application topically in 60 and 30% acetone.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
coconut oil
Concentration / amount:
Intradermal: 7.5% in 5% acetone in Coconut oil: Topical application 60% weight in acetone: Challenge application topically in 60 and 30% acetone.
No. of animals per dose:
20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml of 7.5% w/v of test material in 5% acetone in alembicol D
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml of 7.5% w/v of test material in 5% acetone in alembicol D. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% formaldehyde
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% formaldehyde. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1ml of 7.5%solution of test material in 5% acetone in Alembicol
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1ml of 7.5%solution of test material in 5% acetone in Alembicol. No with. + reactions: 0.0. Total no. in groups: 10.0.

In vivo (LLNA)

Results
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not tested

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this test performed with albino guinea pigs the test material did not produce evidnec of skin snesitisation ( delayed contact hypersensitivity)
Executive summary:

Information from migrated NONS file, as per inquiry 06-0000020508-70-0000, permission to refer granted by ECHA