Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this data is not owned by the registrant . The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, data are not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

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:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-240-4
EC Name:
-
Cas Number:
96478-09-0
Molecular formula:
C18 H17 N3 O3
IUPAC Name:
2-[3-(2H-1,2,3-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl 2-methylprop-2-enoate

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
This information was not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: PEG 400
Concentration / amount:
0.1 ml
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: PEG 400
Concentration / amount:
0.1 ml
No. of animals per dose:
10 animals in each test group and 5 animals in the negative control group
Challenge controls:
For the challenge control a 25% solution of test material in PEG was used.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
This information was not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0% solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0% solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25% solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25% solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections. Some of the animals experienced a very slight erythematous reaction at the 24 and 48 hour mark..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
None of the animals within the study have showed signs of sensitisation. Therefore the test material has been classed as not sensitising to the skin.
Executive summary:

The study has been conducted according to EU Method B6 of Directive 92/69 EEC. The test material has been determined to show no signs of sensitisation, as none of the animals within the study have shown signs of skin sensitisation.