Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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: 610-641-3 | CAS number: 512802-65-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-10-08 to 2009-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- April 29, 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted prior to LLNA being accepted as a TG.
Test material
- Reference substance name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- EC Number:
- 500-094-8
- EC Name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- Molecular formula:
- C6H15O3N(C3H6O)n ; n >1 and n< 6.5
- IUPAC Name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- Details on test material:
- - Name of test material (as cited in study report): NLP #15 (2,2',2''-Nitrilotriethanol, propoxylated)
- Molecular weight (if other than submission substance): 340 g/mol
- Physical state: liquid
- Analytical purity: 100 %
- Purity test date: 2008-08-28
- Lot/batch No.: 2224R01
- Expiration date of the lot/batch: 26-Feb-2009
- Storage condition of test material: at room temperature in the dark
- Stability: Stable in water for at least 6 months if stored in the dark
or under diffuse light and/or in limited access of air;
unknown in a 1:1 (v/v) mixture of FCA/physiological
saline; is excluded from the statement of compliance.
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 Albino Dunkin Hartley Guinea Pig, CRL:(HA)BR, SPF (Specific Pathogen Free)
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 538-704 g
- Housing:Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard guinea pig breeding / maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland) ad lib.
-Water (e.g. ad libitum):Community tap water ad lib.
- Acclimation period: under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2008-11-12 to 2008-12-09
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 5% for intradermal induction, 100% for epidermal induction;
75% for epidermal challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% for intradermal induction, 100% for epidermal induction;
75% for epidermal challenge
- No. of animals per dose:
- 10 control animals and 20 test animals
- Details on study design:
- RANGE FINDING TESTS:
Intradermal pretest (together with Freund's) in two animals, 75-50-25-15-10 and 5 %. Dermal reactions were assessed 24 hours later based on the results, the test item concentration of 5 % (w/w) was selected for intradermal induction in the main study.
Epidermal pretest (after Freund's) in two animals, 100-75-50 and 25 %. Based on the results, the test item concentration of 75 % (w/w) was selected for epidermal challenge and 100% as lowest irritating concentration for epidermal induction.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x intradermal, 1 x epicutaneous
- Exposure period: intradermal-continuous, epicutaneous: 48 h
Test group:
intradermal induction:
in parallel intradermal injection of Freund's complete adjuvant, test item (5% ) in purified water, Freund's/test item (5%) 1:1
epidermal induction:
100% test item, occlusive conditions, 48 h
- Control group:
intradermal induction:
in parallel intradermal injection of Freund's complete adjuvant, purified water, Freund's/purified 1:1
epidermal induction:
purified water, occlusive conditions, 48 h
- Site: dorsal skin from the scapular region (intradermal and epicutaneous)
- Frequency of applications: once
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: test item (75%) / water
- Control group: test item (75%) / water
- Site: left flank
- Evaluation (hr after challenge): 24 h, after depilation - Challenge controls:
- No re-challenge
- Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- 90% of positive responders in test group, 0% in control group
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- purified water only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- purified water only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the control group
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the control group.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the test group
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the test group
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: NLP#15 (2,2’,2’’-Nitrilotriethanol, propoxylated), 75 % in purified water . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- purified water only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- purified water only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic toxicity and/or deaths were noted in the guinea pigs of the test group.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: purified water only . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic toxicity and/or deaths were noted in the guinea pigs of the test group..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- ALPHA-HEXYLCINNAMALDEHYDE at 1 % in PEG 300
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Discrete/patchy to moderate/confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- ALPHA-HEXYLCINNAMALDEHYDE at 1 % in PEG 300
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Discrete/patchy to moderate/confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- ALPHAHEXYLCINNAMALDEHYDE at 0.1 % in PEG 300
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- discrete/patchy erythema
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin sensitizing potential was identified in the guinea pig Maximization-test with the substance.
- Executive summary:
The skin sensitizing potential of the substance was investigated in a guinea pig maximisation test according to OECD 406. Male guinea pigs were treated intradermally (together with Freund's adjuvant) and epicutaneously (lowest irritating concentration) with the test item. Twenty one days after first administration, the substance was applied epicutaneously at the highest non-irritating concentration. The local reactions recorded in the eight test animals (40 %) after the challenge were considered to be of irritant nature. This interpretation is supported by the fact that the reactions faded at the 48-hour reading and that 60 % of the control animals also showed a local erythema at the 24 -hour reading.
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, the substance does not have to be classified and labelled as a skin sensitizer.
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.