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EC number: 266-357-1 | CAS number: 66422-95-5
- 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:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 406 and in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Available study not conducted specifically for REACH.
Test material
- Reference substance name:
- 2-(2,4-diaminophenoxy)ethanol dihydrochloride
- EC Number:
- 266-357-1
- EC Name:
- 2-(2,4-diaminophenoxy)ethanol dihydrochloride
- Cas Number:
- 66422-95-5
- Molecular formula:
- C8H12N2O2.2ClH
- IUPAC Name:
- 2-(2,4-diaminophenoxy)ethan-1-ol dihydrochloride
- Details on test material:
- Test item : Imexine OAJ
EC number : 266-357-1
Batch number : 0101297
Purity : 99.6%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: ~3 months old
- Weight at study initiation: 347+/-9g for males and 339+/-9g for females
- Housing: Individually in polycarbonate cages (48cm x 27cm x 20cm)
- Diet : Free access to 106 pelleted diet (UAR, Villemoisson-sur-Orge, France)
- Water : Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: At least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12 cyles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 500 mg undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 500 mg undiluted
- No. of animals per dose:
- Number of animals : 15 animals of each sex
Number of control animals : 5 male, 5 female
Number of treated animals : 10 male, 10 female - Details on study design:
- The sites to be treated were clipped and/or shaved before each induction or challenge application. The concentration of Imexine OAJ used for challenge and induction applications was selected on the basis of the results of a preliminary irritation test where undiluted Imexine OAJ was non-irritant under the conditions of the study. The induction procedure consisted of 3 weekly topical applications of neat Imexine OAJ. On day 1, a moistened gauze pad (about 4 cm2) dampened with 0.5 ml water or loaded with 500 mg neat Imexine OAJ was applied to the anterior left flank of control (5/sex) or treated (10/sex) animals, respectively. It was held in place for 6 hours by an occlusive dressing. This treatment was repeated on day 8 and day 15 of the study. On day 29, following a 2- week rest period, all control and treated animals received under similar conditions a topical challenge application of 0.5 ml water and 500 mg neat Imexine OAJ on posterior left and right flank, respectively. Cutaneous reactions were assessed 24 hours after each dressing removal during the induction period, and 24, 48 and 72 hours after removing the dressing of challenge application.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro-1-chlorobenzene
Results and discussion
- Positive control results:
- Under the experimental conditions and according to the Buehler method (3 applications) the substance 2,4-dinitro-1-chlorobenzene at the concentration of 0.5% induced positive skin sensitisation reactions in 33% of the guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 500 mg. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
- Reading:
- 2nd reading
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 2nd reading. Group: test group. Dose level: 500 mg. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
- Reading:
- other: 3rd reading
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 3rd reading. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 500 mg. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
- Reading:
- other: Challenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 72.0. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Well defined erythema
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Well defined erythema.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Very slight-well defined erythema, dryness of skin
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Very slight-well defined erythema, dryness of skin.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the topical application of undiluted Imexine OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) did not produce sensitisation reactions.
- Executive summary:
The potential of the substance to produce sensitisation reactions was assessed according to OECD guideline 406 in compliance to GLP. The sites to be treated were clipped and/or shaved before each induction or challenge application. The concentration of Imexine OAJ used for challenge and induction applications was selected on the basis of the results of a preliminary irritation test where undiluted Imexine OAJ was non-irritant under the conditions of the study. The induction procedure consisted of 3 weekly topical applications of neat Imexine OAJ. On day 1, a moistened gauze pad (about 4 cm2) dampened with 0.5 ml water or loaded with 500 mg neat Imexine OAJ was applied to the anterior left flank of control (5/sex) or treated (10/sex) animals, respectively. It was held in place for 6 hours by an occlusive dressing. This treatment was repeated on day 8 and day 15 of the study. On day 29, following a 2- week rest period, all control and treated animals received under similar conditions a topical challenge application of 0.5 ml water and 500 mg neat Imexine OAJ on posterior left and right flank, respectively. Cutaneous reactions were assessed 24 hours after each dressing removal during the induction period, and 24, 48 and 72 hours after removing the dressing of challenge application.Cutaneous reactions were limited to purple colouration of the skin and very slight erythema in 2/20 treated animals at the 48 hour reading. Under the conditions of the study, the topical application of undiluted Imexine OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) did not produce sensitisation reactions.
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