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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
the study has been conducted before existence of validated LLNA-Guideline

Test material

Constituent 1
Chemical structure
Reference substance name:
Dioctyl ether
EC Number:
211-112-6
EC Name:
Dioctyl ether
Cas Number:
629-82-3
Molecular formula:
C16H34O
IUPAC Name:
1-(octyloxy)octane
Test material form:
liquid
Details on test material:
- State of aggregation: Colorless, clear liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Di-n-Octyl Ether
- Physical state: liquid
- Analytical purity/active matter: >99,9%
- Lot/batch No.: S910331
- Expiration date of the lot/batch: 1992-09-07
- Stability: stable for at least 1 year
- Storage condition of test material: at room temperature, in a dark closed vessel

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
according to guideline

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
2 %
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
10%
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
5 %
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
3 %
No. of animals per dose:
20
Details on study design:
according to guideline
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:
5%
No. with + reactions:
14
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
9
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
5
Total no. in group:
10
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
10
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
3
Total no. in group:
10
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
3
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
1
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Both controls and treated animals exhibited weak reactions that were attributed to irritation. Following rechallenge, no distinct dermal effects were observed.
Executive summary:

A test according to the Magnusson and Kligman method was performed with the test article to investigate the sensitizing potential with female guinea pigs, strain Pirbright White. The test substance was applied as a 2% dilution in paraffin perliquid for the intracutaneous and as a 10% dilution for the epicutaneous induction. Concentration for the challenge was 5%. 24 hours after the removal of the challenge patches the test substance solution did not cause any dermal reactions, which could be attributed to allergic reactions. The substance is therefore not considered to be a sensitizer.