Registration Dossier
Registration Dossier
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EC number: 906-891-0 | CAS number: -
Skin sensitisation
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: Performed under GLP and according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Non LLNA stury results where already available at the time of registration.
Test material
- Reference substance name:
- (2-aminoethyl)({2-[(2-aminoethyl)amino]ethyl})amine; (2-aminoethyl)[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amine; 2-({2-[(2-aminoethyl)amino]ethyl}amino)ethan-1-ol; 2-[(2-hydroxyethyl)amino]ethan-1-ol
- EC Number:
- 906-891-0
- Cas Number:
- 84238-53-9
- Molecular formula:
- UVCB substance and no specific formula
- IUPAC Name:
- (2-aminoethyl)({2-[(2-aminoethyl)amino]ethyl})amine; (2-aminoethyl)[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amine; 2-({2-[(2-aminoethyl)amino]ethyl}amino)ethan-1-ol; 2-[(2-hydroxyethyl)amino]ethan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: avid Hall
Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks old.
- Weight at study initiation: 328 to 395g
- Housing: ingly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -22
- Humidity (%): 48-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Concentration / amount:
- Intradermal Induction: 0.5% w/v in distilled water, 0.5% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
(1: 1)
Topical Induction: 25% v/v in distilled water
Topical Challenge: 25% and 10% v/v in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- Intradermal Induction: 0.5% w/v in distilled water, 0.5% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
(1: 1)
Topical Induction: 25% v/v in distilled water
Topical Challenge: 25% and 10% v/v in distilled water
- No. of animals per dose:
- 5 control, 10 test animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% and 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is sensitising to guinea pig skin
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