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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1993 when the LLNA was not available as an established method.

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dioxane
EC Number:
204-661-8
EC Name:
1,4-dioxane
Cas Number:
123-91-1
Molecular formula:
C4H8O2
IUPAC Name:
1,4-dioxane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchsstierzucht, Hagemann GmbH&Co.
- Weight at study initiation: 293-345 gram
- Housing: 5 per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal induction: 5%
epicutaneous induction: 100%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
No. of animals per dose:
control group (0.9% aqueous NaCl-solution): 5 animals
test group: 10 animals
Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitro-benzol

Results and discussion

Positive control results:
The results showed that the test system was able to detect skin sensitizers.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
20
Total no. in group:
20

Any other information on results incl. tables

Upon intradermal induction well-defined signs of erythema and oedema were observed. Upon percutaneous induction incrustation, well-defined erythema and slight oedema were noted, but these were caused by the intradermal induction.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met