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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
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