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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexadecan-1-ol
EC Number:
253-149-0
EC Name:
Hexadecan-1-ol
Cas Number:
36653-82-4
Molecular formula:
C16H34O1
IUPAC Name:
Hexadecan-1-ol
Constituent 2
Chemical structure
Reference substance name:
2-(hexadecyloxy)ethanol
EC Number:
218-373-5
EC Name:
2-(hexadecyloxy)ethanol
Cas Number:
2136-71-2
Molecular formula:
C18H38O2
IUPAC Name:
2-(hexadecyloxy)ethanol
Constituent 3
Chemical structure
Reference substance name:
2-[2-(Hexadecyloxy)ethoxy]ethanol
EC Number:
610-892-9
Cas Number:
5274-61-3
Molecular formula:
C20H42O3
IUPAC Name:
2-[2-(Hexadecyloxy)ethoxy]ethanol
Constituent 4
Chemical structure
Reference substance name:
2-[2-[2-(Hexadecyloxy)ethoxy]ethoxy]ethanol
Cas Number:
4484-59-7
Molecular formula:
C22H46O
IUPAC Name:
2-[2-[2-(Hexadecyloxy)ethoxy]ethoxy]ethanol
Constituent 5
Chemical structure
Reference substance name:
2-[2-[2-(2-hexadecoxyethoxy)ethoxy]ethoxy]ethanol
Cas Number:
5274-63-5
Molecular formula:
C24H50O5
IUPAC Name:
2-[2-[2-(2-hexadecoxyethoxy)ethoxy]ethoxy]ethanol
Constituent 6
Chemical structure
Reference substance name:
Octadecan-1-ol
EC Number:
204-017-6
EC Name:
Octadecan-1-ol
Cas Number:
112-92-5
Molecular formula:
CH3(CH2)17OH
IUPAC Name:
octadecan-1-ol
Constituent 7
Chemical structure
Reference substance name:
2-(octadecyloxy)ethanol
EC Number:
218-374-0
EC Name:
2-(octadecyloxy)ethanol
Cas Number:
2136-72-3
Molecular formula:
C20H42O2
IUPAC Name:
2-(octadecyloxy)ethanol
Constituent 8
Chemical structure
Reference substance name:
2-[2-(Octadecyloxy)ethoxy]ethanol
EC Number:
605-213-8
Cas Number:
16057-43-5
Molecular formula:
C22H46O3
IUPAC Name:
2-[2-(Octadecyloxy)ethoxy]ethanol
Constituent 9
Chemical structure
Reference substance name:
2-[2-[2-(Octadecyloxy)ethoxy]ethoxy]ethanol
EC Number:
610-180-8
Cas Number:
4439-32-1
Molecular formula:
C24H50O
IUPAC Name:
2-[2-[2-(Octadecyloxy)ethoxy]ethoxy]ethanol
Constituent 10
Chemical structure
Reference substance name:
2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethanol
Cas Number:
59970-10-4
Molecular formula:
C26H54O5
IUPAC Name:
2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethanol
Constituent 11
Chemical structure
Reference substance name:
2-[2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
Cas Number:
71093-13-5
Molecular formula:
C28H58O6
IUPAC Name:
2-[2-[2-[2-(2-octadecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
Test material form:
liquid
Specific details on test material used for the study:
Trade Name: MArlipal 1618/1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Accoding to Guideline.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Induction: 100%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Challenge: 100%
No. of animals per dose:
Test group: 20
Control: 10
Positive control substance(s):
no
Remarks:
historical data

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met