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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Split Adjuvant Test due to limited solubility, but no positive control included.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive control substance included
GLP compliance:
yes
Type of study:
split adjuvant test
Justification for non-LLNA method:
The 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:
N-octadecylstearamide
EC Number:
236-276-6
EC Name:
N-octadecylstearamide
Cas Number:
13276-08-9
Molecular formula:
C36H73NO
IUPAC Name:
N-octadecyloctadecanamide

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Olac, Great Britain
- Age at study initiation: 2 months
- Weight at study initiation: 321-438 g
- Housing: 4 per cage in metal cages with wire-mesh floors (RUCO, Valkenswaard). Distal parts of both rear feet were wrapped with adhesive tape (Sleek, Smith and Nephew, England) to prevent skin injuries.
- Diet: Standard guinea pig diet including ascorbic acid (1600 mg/kg), obtained from Hope Farms, Woerden (LC 23-B, pellet diameter 4 mm), availability not specified. In addition, once a week hay was provided.
- Water: Not specified.
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.0
- Humidity (%): 50-80
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Remarks:
SAT: test substance in corn oil only applied epicutaneously, not injected
Concentration / amount:
0.2 mL of 25% (w/v) on day 0 and 2;
5% (w/v) on day 4 and 7
Day(s)/duration:
8 days
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Remarks:
SAT: test substance in corn oil only applied epicutaneously, not injected
Concentration / amount:
50 µL of 25, 5, 1 and 0% (w/v) on day 21
Day(s)/duration:
Day 21
No. of animals per dose:
20 females in test group, 10 in control group
Details on study design:
RANGE FINDING TESTS:
Before challenge phase a primary irritation test was carried out with 4 guinea pigs in order to find a concentration for challenge not inducing substantial irritation. Four guinea pigs were shaved and their left flank was exposed for 24 hours to 25, 10, 2.5 and 1% (w/v) of the test substance in corn oil under occlusive conditions; application was done in plastic Square chambers (v.d. Bend, Brielle, The Netherlands) provided with aluminium foil to avoid contact with the compound. One animal died from bandage-induced stress, but the remaining animals showed no skin response to any of the tested concentrations.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Test groups: test substance in corn oil epicutaneously under occlusive conditions on day 0, 2, 4 and 7 (on day 0 treatment of skin with dry ice for 5 seconds prior to application); additionally 2 i.d. injections of 0.1 mL FCA on day 4 on either side of sensitisation area.
- Control group: 2 i.d. injections of 0.1 mL FCA on day 4 on either side of sensitisation area.
- Site: Shaved area of 2x2 cm on the back just behind the right shoulder girdle, injections were done on either side of the sensitisation area. The animals were wrapped in a "window dressing" consisting of Lenkelast elastic bandage (Lohmann, Neuwied, FRG) into which a 2x2 cm opening had previously been cut. This opening was placed over the sensitisation site. After applications the site was covered with a Metalline-patch (Lohmann), which was held in place by covering with water-impermeable tape (Sleek, Smith and Nephew, England).
- Frequency of applications: 2 days
- Duration: 8 days
- Concentrations: Test group: 0.2 mL of 25% (w/v) on day 0 and 2, and 5 % (w/v) on day 4 and 7

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: test substance in corn oil under occlusive conditions
- Control group: test substance in corn oil under occlusive conditions
- Site: Application of test substance to the shaved left flank by patches consisting of 1 cm² filter paper (Schleicher & Schull), attached to a piece of aluminium foil with petrolatum, the aluminium foil being mounted on non-irritating Micropore tape (3M Co. St. Paul, USA). The animals were then wrapped in Coban elastic bandage (Smith and Nephew, England). The dressing was fixed in place for 24 hours.
- Concentrations: 50 µL of 25, 5, 1 and 0% (w/v)
- Evaluation (hr after challenge): 48 and 72 hours (24 and 48 hours after removal of the bandage and a close shave of the skin)
Challenge controls:
Control group also serves as challenge control, as injection of these animals with FCA alone on day 4 of the induction should not elicit any sensitivities.
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control was included.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
18
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
18
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
18
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
18
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
18
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
18
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
18
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
18
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
Skin reddening observed at this site should be attributed to mechanical injury (probably shaving). Site excluded from evaluation.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Two animals of the test group had died from bandage-induced stress, one on day 2 and the other one on day 8.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.