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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

skin sensitisation (guinea pig, GPMT): not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
according to guideline
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
2 %
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
10%
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Based on the reliability and relevance, this study has been used as key study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on results of the key study the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008).