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: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's Complete Adjuvant and physiological saline (intradermal and epidermal induction); bi-distilled water with one drop of tween 80 (intradermal and epidermal induction, challenge)
Concentration / amount:
Intradermal induction:
a) (0.1 mL) 1:1 (V/V) mixture of Freund's Complete Adjuvant and physiological saline
b) The test article, diluted to 5% with bi-distilled water with one drop of tween 80
c) The test article diluted to 5% by emulsion in a 1:1 (V/V) mixture of Freund's Comlete Adjuvant and physiological saline

Epidermal induction:
a) (0.1 mL/site) of a 1:1 (V/V) mixture of Freund's Complete Adjuvant/physiological saline
b) (0.2 mL/site) of 50%, 25%, 15 % and 10% in bi-distilled water with one drop of tween 80

Concentration of test material and vehicle used for each challenge:
15% in bi-distilled water with one drop of tween
Challengeopen allclose all
Route:
other: no data
Vehicle:
other: Freund's Complete Adjuvant and physiological saline (intradermal and epidermal induction); bi-distilled water with one drop of tween 80 (intradermal and epidermal induction, challenge)
Concentration / amount:
Intradermal induction:
a) (0.1 mL) 1:1 (V/V) mixture of Freund's Complete Adjuvant and physiological saline
b) The test article, diluted to 5% with bi-distilled water with one drop of tween 80
c) The test article diluted to 5% by emulsion in a 1:1 (V/V) mixture of Freund's Comlete Adjuvant and physiological saline

Epidermal induction:
a) (0.1 mL/site) of a 1:1 (V/V) mixture of Freund's Complete Adjuvant/physiological saline
b) (0.2 mL/site) of 50%, 25%, 15 % and 10% in bi-distilled water with one drop of tween 80

Concentration of test material and vehicle used for each challenge:
15% in bi-distilled water with one drop of tween
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
15 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
15 %
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: 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 15 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15 %
No. with + reactions:
0
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 15 %. No with. + reactions: 0.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 15 %

Evidence of sensitisation of each challenge concentration: None

Other observations: No toxic symptons were evident in the guinea pigs of the control or test group. No deaths occurred.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
On the basis of these results and under the experimental conditions the test substance did not appear to possess sensitising capacity.
Executive summary:

The test substance was tested to be non sensitising to the skin of guinea pigs in a GLP study according to EU Method B.6.