Registration Dossier
Registration Dossier
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EC number: 905-898-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to guidelines and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- A skin sensitisation study according to OECD 406 with adequate quality was already available, and therefore a further LLNA study was not needed to be developed.
Test material
- Reference substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- Molecular formula:
- C6H15NO3
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
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
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 310 - 396g
- Housing: housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access to mains tap water and food (Guinea Pig FDI Diet, Special Diets Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 23
- Humidity (%): 56-67
- 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
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Intradermal induction: i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1, ii) 1% w/v dilution of test material in distilled water., iii) 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Epicutaneous induction: Undiluted material, 0.2 - 0.3 ml applied to filter paper
Challenge: 75% and 50 % v/v in distilled water.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Intradermal induction: i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1, ii) 1% w/v dilution of test material in distilled water., iii) 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Epicutaneous induction: Undiluted material, 0.2 - 0.3 ml applied to filter paper
Challenge: 75% and 50 % v/v in distilled water.
- No. of animals per dose:
- 10 animals+ 5 in control
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on results from triethanolamine, the major constituent of the multiconstituent substance, it is concluded that the substance is a weak sensitiser, no labelling is required.
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