Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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