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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
OECD guideline and GLP conform well documented scientific study report. Rational for read across: N-Tridecyldiisopropanolamin i.e. analogue substance, and the registration substance and/or its presumed metabolites belongs to alkoxylated (ethoxylated/propoxylated) fatty amine, for which comparable biotransformation and toxicity can be reasonably derived.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Designation: Pirbright White, Dunkin, Hartley HOE DHPK (SPF-LAC) guinea pig
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, OW-4923 Extertal 1, Germany
- Housing: Makrolon, type IV, 5 animals per cage
- Body weight at the beginning of the study: 278-328 g
- Diet: Kliba 341, 4 mm (rabbit-guinea pig-feed) ad libitum
- Water: ad libitum; tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light):12/12

Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
Intradermal induction: 0.1 ml solution with 5% test substance
Percutaneous induction: 0.3 g formulation with 25% test substance
Challenge: 0.15 g formulation with 10% test substance
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Intradermal induction: 0.1 ml solution with 5% test substance
Percutaneous induction: 0.3 g formulation with 25% test substance
Challenge: 0.15 g formulation with 10% test substance
No. of animals per dose:
10 (Test group)/ 5 (Control groups)
Details on study design:
RANGE FINDING TEST:
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance formulation.
Exposure period:
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitisation reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application :
- Flank, respective on the same area
Number of test animals :
- 4 per test concentration
Readings :
- About 24 and 48 h after the beginning of application

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: 2
- Test groups: 1: A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0 .9% aqueous NaCl-solution in a ratio of 1:1 B) middle row : 2 injections each of 0.1 ml of the test substance formulation (5% in olive oil) C) back row: 2 injections each of 0.1 ml 5% test substance in A)
- Control group: 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site: Shoulder
- Frequency of applications: once
- Duration: 7 days (reading after 24 h)

Percutan:
- No. of exposures: 1
- Test group: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. In the case of liquids the filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance in olive oil (25%).
- Control groups: Both control groups were treated analogously to the test group but only with the solvent without the test substance
- Site: Shoulder
- Frequency of applications: once
- Duration: 48 h

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: 21 (after intradermal induction)
- Exposure period: 24 h
- Test group: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance in olive oil (10%).
Challenge :
- Treatment of the test group with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle.
- Control group: 2: control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle. Control group 2 only received olive oil DAB 9 .
- Site: flank
- Evaluation (h after challenge): 24 and 48 h after removal of the patch

Challenge controls:
yes, (control group 2)
Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitro-benzol
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% in olive oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% in olive oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
edema and erythema of varying degree
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: edema and erythema of varying degree.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Negative control group 1
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Negative control group 1
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Negative control group 2
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Negative control group 2
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance N-Tridecyldiisopropanolamin, CAS 62889-66-1, does not induce delayed contact hypersensitivity in guinea pigs.
Executive summary:

The potential of the test item substance N-Tridecyldiisopropanolamin CAS 62889-66-1 to induce delayed contact hypersensitivity was evaluated in guinea pigs according to the maximization method of Magnusson and Kligman and EEC directive 84/449, (Publication No. L251, B.6, Sept. 19, 1984) guideline. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.Twenty guinea pigs were allocated to three groups: two control groups (one serves as reserve group) of five females each and one treated group of ten females.

Intradermal injections were performed in the shoulder region of all animals on day 1 according to study plan. Test itemconcentration of 0.5 % in olive oil (v/v) was chosen based on results of a preliminary study.

On day 8 epidermal induction was performed. The animals of the test group received a topical application of the test item at the concentration of 25% (w/w) in olive oil to the same test site as previously treated by intradermal injections, which was then covered by an occlusive dressing for 48 hours. The animals of the control group received an application of the vehicle under the same experimental conditions.

On day 21, epidermal challenge was performed. All animals of test group and first control group were challenged by a cutaneous application of the test item at the concentration of 10% (w/w) olive oil to the intact clipped right flank. The test item was maintained under an occlusive dressing for 24 hours. The vehicle was applied to the intact clipped left flank of first control group under the same experimental conditions. The second control group (reserve group) received the vehicle alone at the intact clipped left flank under the same experimental conditions. Skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing.

Result: No systemic clinical signs and no deaths were noted during the study.No relevant cutaneous reactions were observed after the challenge application.Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance N-Tridecyldiisopropanolamin, CAS 62889-66-1, does not induce delayed contact hypersensitivity in guinea pigs.

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

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, both the analogue test substances N-Tridecyldiisopropanolamin CAS no. 62889 -66 -1 and Tri(Z) -2,2’-(Octadec-9-enylimino) bisethanol CAS no. 13127-82-7 do not induce delayed contact hypersensitivity in guinea pigs.

Rationale for the read-across: The analogue substances as well as the registration substance and/or its presumed metabolites belongs to alkoxylated (ethoxylated/propoxylated) fatty amine, for which comparable biotransformation and toxicity can be reasonably derived.


Migrated from Short description of key information:
In order to assess the skin sensitization potential of the registration substance, a skin sensitisation test in the guinea pig (maximisation method of Magnusson and Kligman) according to OECD 406 with an analogue substance is available. Further, a supporting study with a second analogue substance is available for assessment.

Justification for selection of skin sensitisation endpoint:
Rationale for the reliability: GLP, fully OECD 406 compliant.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, both the analogue test substances N-Tridecyldiisopropanolamin CAS no. 62889 -66 -1 and Tri(Z) -2,2’-(Octadec-9-enylimino) bisethanol CAS no. 13127-82-7 do not induce delayed contact hypersensitivity in guinea pigs. Thus, it is considered, that no classification is warranted for the registration substance according to the OECD GHS criteria.