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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test
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 chemical
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 chemical
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.