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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD method, CLP compliance

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Magnusson & Kligman OECD Guideline 406 (1981) EEC Directive 84/449 (1984)Annex V - Method B6
GLP compliance:
yes
Type of study:
other: not provided

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-110-2
EC Name:
-
Cas Number:
135861-56-2
Molecular formula:
C24H30O6
IUPAC Name:
(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

In vivo test system

Test animals

Species:
other: Albino Hartley Guinea-pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Test article in a 0.1 % (WIW) suspension in abs. ethanol.

Concentration of test material and vehicle used for each challenge:

Test article in a 50 % (W/W) paste in absolute ethanol.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Test article in a 0.1 % (WIW) suspension in abs. ethanol.

Concentration of test material and vehicle used for each challenge:

Test article in a 50 % (W/W) paste in absolute ethanol.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
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:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
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

Maximum concentration not causing irritating effects in preliminary test:50%

Signs of irritation during induction: Yes

Evidence of sensitisation of each challenge concentration: None

Other observations: /

Applicant's summary and conclusion

Interpretation of results:
other: not classified