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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997/06/18 - 1997/07/18
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17th July 1992
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Dioctadecyl ether
EC Number:
228-567-1
EC Name:
Dioctadecyl ether
Cas Number:
6297-03-6
Molecular formula:
C36H74O
IUPAC Name:
1-(octadecyloxy)octadecane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: 76410 Saint-Aubin-Les-Elbeuf, France
- Weight at study initiation: 330g-387g
- Housing: individual polypropylene cages
- Diet: Complete pelleted diet UAR 106 (91360 -Epinay sur Orge, France)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
in accordance with the requirements of the 86/609/EEC guideline

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral oil
Concentration / amount:
50% and 20% of the testsubstance diluted with mineral oil for challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral oil
Concentration / amount:
50% and 20% of the testsubstance diluted with mineral oil for challenge
No. of animals per dose:
treated group: 20 animals
negative control group: 10 animals
Details on study design:
Pilot study

In order to find the maximum non-irritant concentration for the skin a pre-test was carried out. 4 guinea-pigs were closely-clipped at the dorsal level over a surface area of approximately 60 cm2. They received on both sides of the spinal column, for 6 hours under an occlusive patch, 0.5 mL of the test substance, diluted at 50 %, 20 %, 10 % and 5 % with mineral oil, and the vehicle only. The cutaneous irritation reactions were assessed 24 and 48 hours after patches removal. The concentration of test substance retained for the challenge exposure was the highest non-irritating dose.

Determination of the sensitizing potential

For determination of the senstizing potential 20 guinea pigs (group 2) were treated and compared with 10 guinea pigs (group 1) which received the vehicle only (mineral oil).

Induction

Day 1 - treated group (group 2)
Left flank of each guinea-pig was closely-clipped. One hour later, a square cotton pad of 4 cm2 fully loaded (0.5 mL) with test material diluted at 50 % with mineral oil, was applied to the test area and held in contact for 6 hours with the skin by an occlusive patch.

Day 1 - control group (group 1)
Left flank of each animal was closely-clipped. One hour later, the vehicle only (mineral oil), was applied in a similar manner to that used for the treated group. The test patch system was held in contact with the skin by an occlusive patch for 6 hours.

Days 8 and 15 - treated group and control group
One hour before topical applications, left flank of all the animals was closely-clipped. The same application as on day 1 was carried out on the same test area of the same flank on day 8, and again on day 15.

Challenge

Day 29 - treated group and control group
Following a rest period of 14 days, the untreated flank (right flank) of all treated and control animals was closely-clipped. One hour after, we applied under an occlusive patch, to the posterior untreated flank of each of the guinea-pigs, two square cotton pads of 4 cm2 moistened with 0.5 mL of the test material diluted at 50 % (maximum non-irritant concentration) and 20 % with mineral oil and a third cotton pad moistened with vehicle only.
The occlusive patches were held in contact with the skin for 6 hours, then removed.

Day 30 and 31 - treated group and control group
Approximately 24 hours after removing patches, the skin reactions were observed and recorded
Approximately 24 hours later, a second observation (48 hours after patch removal) was made and recorded once again.
All skin reactions and unusual findings observed during the induction and challenge procedures were recorded.
Animals were weighted at the start and at the conclusion of the test.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%, 50% of testsubstance diluted with mineral oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
non
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%, 50% of testsubstance diluted with mineral oil . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: non.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%, 50% of the test substance diluted with mineral oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
non
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%, 50% of the test substance diluted with mineral oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: non.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20%, 50% of the test substance diluted with mineral oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
non
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%, 50% of the test substance diluted with mineral oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: non.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20%, 50% of the test substance diluted with mineral oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
non
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%, 50% of the test substance diluted with mineral oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: non.

Any other information on results incl. tables

One animal of the treated group died on day 4. This mortality was not attributable to the treatment but to a lung pathology. The general state of health of all other animals remained satisfactory throughout the test. The weight growth of all the animals was satisfactory.

Applicant's summary and conclusion