Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-727-3 | CAS number: 68909-99-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed under GLP regulations. For read across justification please refer to IUCLID chapter 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An already available study was used instead of conducting a new study.
Test material
- Reference substance name:
- N,N'-bis(3-aminopropyl)ethylenediamine
- EC Number:
- 234-147-9
- EC Name:
- N,N'-bis(3-aminopropyl)ethylenediamine
- Cas Number:
- 10563-26-5
- Molecular formula:
- C8H22N4
- IUPAC Name:
- N1,N1'-1,2-ethanediylbis(1,3-propanediamine)
- Details on test material:
- - Name of test material (as cited in study report): N4-Amine (N,N-bis(3-aminopropyl)ethylenediamine)
- Analytical purity: 98.3 peak area-% (analytical report No.: 04L00300)
- Batch identification: Behaelter 1716
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: Dunkin Hartley, Crl:HA
- Source: Charles River Laboratories, Kisslegg - Germany
- Age at study initiation: 5 – 8 weeks
- Weight at study initiation: 377 g – 440 g
- Housing: The animals were housed in fully air-conditioned rooms (5 animals per cage)
- Cage type: Plastic cages with perforated base; floor area: 4000 cm² (Tecniplast Deutschland GmbH)
- Diet (e.g. ad libitum): Kliba Labordiaet (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 14 days before the first test-substance application.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Doubly distilled water
- Concentration / amount:
- All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Doubly distilled water
- Concentration / amount:
- All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen.
- No. of animals per dose:
- 5
- Details on study design:
- Pretest:
In a pretest, the irritancy profile was determined by applying 0.5 ml of various concentrations (1%, 5%, 10%, and 25%) of aqueous test substance solutions to a 2-cm² area of the shaved flanks of Guinea pigs under occlusive conditions. Test sites were visually evaluated 1 h, 24 h and 48 h after application of test solutions. In accordance with the OECD Guideline 406 a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.
Induction:
During the induction phase of the main test, 0.5 ml of test solution were applied to an 2-cm² area of the skin of the flank of groups of 5 Guinea pigs three times at weekly intervals, on days 0, 7 and 14 on the same application site. Skin readings were performed 24 h after application. The control animals were not treated since the doubly distilled water used as formulating agent was not expected to influence the result of the study.
Challenge:
Fourteen days after the last induction treatment, each test group animal and animals from control group were challenged with 0.5 ml of 5% aqueous solution of the test substance to a 2-cm² area on the previously untreated flank. Skin reactions were read at 24 and 48 after application of the solutions.
Evaluation:
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 15 per cent of the test animals exhibit skin reactions. - Positive control substance(s):
- no
- Remarks:
- A positive control with a known sensitizer was not included in this study. However, a separate study was performed twice a year in the same laboratory.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% test-substance preparation in doubly distilled water
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Discrete or patchy erythema (grade 1)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Discrete or patchy erythema (grade 1).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% test-substance preparation in doubly distilled water
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- Moderate and confluent erythema (grade 2)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: Moderate and confluent erythema (grade 2).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% test-substance preparation in doubly distilled water
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- (grade 1)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: (grade 1).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% test-substance preparation in doubly distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- (grade 2)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: (grade 2).
Any other information on results incl. tables
Pretest:
The 5% and 1% test-substance preparations in doubly distilled water did not cause any skin reactions. After application of the 25% test-substance preparation moderate and confluent erythema was observed in all animals. The 10% preparation caused discrete or patchy erythema in 2 out of 3 animals. Therefore the 10% test-substance preparations were used for induction whereas the 5% test-substance preparations were applied for challenge.
Induction:
The inductions caused discrete or patchy to intense erythema, swelling and eczematoid skin changes in all test group animals. For the 3rd induction the test patch was moved to the middle of the flank in one test group animal because of severe skin irritation effect.
Skin findings |
Inductions Animals with findings/Animals tested |
||
1st |
2nd |
3rd |
|
Grade 0 |
- |
- |
- |
Grade 1 |
11/20 |
1/20 |
|
Grade 2 |
9/20 |
9/20 |
2/20 |
Grade 3 |
- |
10/20 |
18/20 |
Swelling |
- |
3/20 |
1/20 |
Eczematoid skin change |
- |
- |
17/20 |
Challenge:
After the challenge discrete or patchy to moderate and confluent erythema was observed in the test group animals 24 and 48 hours after removal of the patches.
Skin findings |
Control group |
Test group |
||
24 h |
48 h |
24 h |
48 h |
|
Grade 0 |
10/10 |
10/10 |
8/20 |
4/20 |
Grade 1 |
- |
- |
4/20 |
6/20 |
Grade 2 |
- |
- |
8/20 |
10/20 |
Grading:
0 No visible change
1 Discrete or patchy erythema
2 Moderate and confluent erythema
3 Intense erythema and swelling
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
