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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The publication compared the applicability of LLNA and GPMT to different fatty acids.

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid
EC Number:
204-007-1
EC Name:
Oleic acid
Cas Number:
112-80-1
Molecular formula:
C18H34O2
IUPAC Name:
octadec-9-enoic acid
Specific details on test material used for the study:
Supplier: Sigma Aldrich (Munich, Germany)
Lot No.: O1008
Purity: 99%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc: DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann (Borchen, Germany)
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Weight at study initiation: 300-500 g
- Housing: in groups in Terluran cages on Altromin saw fiber bedding or Lignocel bedding
- Diet (e.g. ad libitum): Altromin 3122 maintenance diet for guinea pigs or ssniff Ms-H, 4mm V2233-000 complete diet for guinea pigs, rich in crude fiber, totally-pathogen-free, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5%
Day(s)/duration:
d0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
other: topical
Vehicle:
other: vaseline
Concentration / amount:
50%
Day(s)/duration:
d7
Challengeopen allclose all
Route:
other: topical
Vehicle:
other: vaseline
Concentration / amount:
25%
Day(s)/duration:
d20
Adequacy of challenge:
highest non-irritant concentration
Route:
other: topical
Vehicle:
other: vaseline
Concentration / amount:
25%
Day(s)/duration:
d28
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 per test group, 5 per control group

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction 5%, challenge 25%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
induction 5%, challenge 25%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
induction 5%, challenge 25%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
induction 5%, challenge 25%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
induction 5%, challenge 25%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Reading:
1st reading
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Remarks on result:
other: for 24 / 48 / 72 h after challenge
Reading:
rechallenge
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
all animals (including controls exhibited skin reactions grade 1, therefore only animals with skin reactions greater 1 were judged as "+ reaction*
Remarks on result:
other: for 24 / 48 / 72 h after challenge

Applicant's summary and conclusion