Registration Dossier
Registration Dossier
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: 203-041-4 | CAS number: 102-60-3
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (BASF AG).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test was performed in accordance to the OECD guideline 406 and can be considered as a validated and reliable testing method for skin sensitization including a high statistical sample size and the challenge phase.
Test material
- Reference substance name:
- 1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol
- EC Number:
- 203-041-4
- EC Name:
- 1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol
- Cas Number:
- 102-60-3
- Molecular formula:
- C14H32N2O4
- IUPAC Name:
- 1-({2-[bis(2-hydroxypropyl)amino]ethyl}(2-hydroxypropyl)amino)propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Neutrol TE
- Physical state: liquid
- Analytical purity: 88.4 %
- Composition of test material, percentage of components: EDA + 3PO, 7.75 %; EDA + 4PO, 88.4 %; EDA + 4PO, 3.35 %
- Lot/batch No.: 36-3224
- Stability under test conditions: tested at completion of all tests
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin-Hartley HOE DHPK [SPF-LAC] BÖ
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co KG, Extertal, Germany
- Weight at study initiation: 250 - 291 g
- Housing: 5/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
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:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 5 % (±FCA); epicutaneous induction: 50 % (corresponding to 0.3 g test substance); 1. Challenge: 25 % (corresponding to 0.15 g test substance); 2. Challenge: 25 % (corresponding to 0.15 g test substance)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 5 % (±FCA); epicutaneous induction: 50 % (corresponding to 0.3 g test substance); 1. Challenge: 25 % (corresponding to 0.15 g test substance); 2. Challenge: 25 % (corresponding to 0.15 g test substance)
- No. of animals per dose:
- Controls: 10; Test group: 20
- Details on study design:
- RANGE FINDING TESTS:
Test substance was applied epicutaneously to the flank 2 times for 24 hours under occlusive dressing in a 96 hour period , readings were performed at 24 and 48 hours after beginning of the application (number of test animals: 3 resp. 4 per concentration). The minimum irritant concentration was found to be a 50 % aqueous test substance preparation and the maximum non-irritant concentration a 25 % aqueous test substance preparation .
Applicability : it was possible to inject a 5 % test substance preparation in aqua dest . resp. in Freund's adjuvant/ aqua dest . (1 : 1) with a syringe .
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1. exposure: injection; 2. exposure: epicutaneous occlusive 48 hours
- Test groups: 1. exposure: A: FCA/water; B: water + 5 % TS; C: FCA/ water + 5 % TS; 2. exposure: 50 % TS
- Control group: 1. exposure: A: FCA/water; B: water; C: FCA/water; 2. exposure: untreated (water would not be considered to cause any effects)
- Site: shoulder, 3 rows of injections (A, B, C)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 14; 21
- Exposure period: 24 hours
- Test groups: 1. challenge: 25 % TS; 2. challenge: 25 % TS
- Control group: group 1: 1. challenge 25 % TS, 2. challenge 25 % TS; group 2: untreated, 2. challenge 25 % TS
- Site: Intact clipped flank: 1. challenge: right flank 25 % TS; 2. challenge: left flank 25 % TS
- Evaluation (hours after challenge): 24, 48, 72 hours after the beginning of the application - Challenge controls:
- Not necessary, control groups were without response after challenge.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: 2nd negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: 2nd negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: 2nd negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: 2nd negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema (barely perceptible)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: very slight erythema (barely perceptible).
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: 2nd negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: 2nd negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- other: 2nd negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: other: 2nd negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
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.
