Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reference study data from SNIF file

Data source

Referenceopen allclose all

Reference Type:
other: SNIF data provided by ECHA
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
secondary source
Title:
Unnamed
Year:
1990

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor:DHPW
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
maize oil
Concentration / amount:
Induction treatments: 10% intradermal and 50% epicutaneous
Challenge: 50%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Induction treatments: 10% intradermal and 50% epicutaneous
Challenge: 50%
No. of animals per dose:
treatment: 20
control: 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:
5
Total no. in group:
20
Clinical observations:
very slight edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: very slight edema.
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:
0%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
very slight edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: very slight edema.
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

On the basis of similarities between the type of skin reactions occurring in test and control groups, the results of a preliminary skin irritation study in which a 50% test dilution produced irritation in 1/3 animals tested, and the nature and degree of the skin reactions normally observed after challenging with standard allergens, the skin reactions in this study were considered to be consistent with signs of skin irritation rather than sensitisation. The results of this study indicate that BNE is not a skin sensitiser in guinea-pigs.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information