Registration Dossier
Registration Dossier
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EC number: 272-712-1 | CAS number: 68909-77-3 The residuum from the reaction of diethylene glycol and ammonia. It consists predominantly of morpholine-based derivatives such as [(aminoethoxy)ethyl]morpholine, [(hydroxyethoxy)ethyl]morpholine, 3-morpholinone, and 4,4'-(oxydi-2,1-ethanediyl)bis[morpholine].
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-10-24 - 1994-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this reliable GPMT test was performed before entry into force of the REACH Regulation.
Test material
- Reference substance name:
- Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues
- EC Number:
- 272-712-1
- EC Name:
- Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues
- Cas Number:
- 68909-77-3
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- 2-(2-hydroxyethoxy)ethan-1-ol; 2-[1-(morpholin-4-yl)ethoxy]ethan-1-amine; 2-{2-[bis(2-hydroxyethyl)amino]ethoxy}ethan-1-ol; 4-{2-[2-(morpholin-4-yl)ethoxy]ethyl}morpholine; morpholin-3-one
- Test material form:
- liquid
- Details on test material:
- Name: Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues
Physical state: liquid
Appearance: brown liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): AMINE C-8
- Substance type: dark brown slightly viscous liquid with crystalline sediment
- Physical state: liquid
- Analytical purity: no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 307-399 g
- Housing: singly or in pairs in solid floor polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): 50-63%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.5% (w/v) in distilled water
Topical induction: undiluted
Topical challenge: 50% and 75% (v/v) in distilled water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.5% (w/v) in distilled water
Topical induction: undiluted
Topical challenge: 50% and 75% (v/v) in distilled water
- No. of animals per dose:
- 10 test animals and 5 control animals
- Details on study design:
- RANGE FINDING TESTS:
For the intradermal injections, 4 animals were injected with 0.1%, 0.5%, 1% or 5% test material and erythema was assessed 24, 48 and 72 hours and 7 days after injection. For the topical induction and challenge, 2 animals were treated with 25%, 50%, 75% and 100% test material under occlusion. The highest concentration without severe irritation after intradermal injection was used in the main test. The highest concentration producing mild-moderate irritation after topical induction was used in the main study. The highest non-irritating dose and one lower dose after topical challenge were used in the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections and one occlusive topical application
- Exposure period: one week between injection and topical application; 48 hours topical application
- Test groups: 0.1 ml injection of 1) FCA + water (1:1); 2) 0.5% test material; 3) 0.5% test material + FCA (1:1)
- Control group: 0.1 ml injection of 1) FCA + water (1:1); 2) water; 3) 50% formulation of FCA + water (1:1)
- Site: 40 mm x 60 mm on shoulder region
- Frequency of applications: one series of 3 injections followed by one topical induction 1 week later
- Duration: 7 days between intradermal and topical induction, 48 hours topical exposure, 24 hours observation after topical exposure
- Concentrations: undiluted test material for topical induction
B. CHALLENGE EXPOSURE
- No. of exposures: 3 per animal
- Day(s) of challenge: 1 day
- Exposure period: 1 day
- Test groups: 50% and 75% of test material (right flank)
- Control group: vehicle (left flank)
- Site: flanks
- Concentrations: 0, 50% and 75%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- Distilled water (vehicle) was used as the negative control.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow-coloured staining
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow-coloured staining
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow-coloured staining
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow-coloured staining
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow-coloured staining
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow-coloured staining
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 2-mercaptobenzothiazole at 5% in arachis oil B.P.
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Group:
- positive control
- Dose level:
- 2-mercaptobenzothiazole at 5% in arachis oil B.P.
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
After intradermal injection, erythema was noted at the exposure sites, mainly in the test group animals (well-defined after 24h and very slight to well-defined after 48h). After topical induction, all test group animals showed yellow-coloured staining and very slight to well-defined erythema. The control group animals did not show skin reactions. After topical challenge, all animals, including control group animals showed yellow-coloured staining. No other skin reactions were observed.
No adverse effects in body weight (gain) was observed when comparing test group animals and control group animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the guinea pig maximisation test, the test material was negative for skin sensitisation.
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