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EC number: 213-195-4 | CAS number: 929-06-6
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Jan - March 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Purity not given. Study was performed according to OECD 406 guideline and in compliance with the GLP Regulations. It is not clear whether 8 or 10 animals were used in the dose-range finding study. It is not clear whether challenge was performed 13 or 14 days after the last induction period. However, it is unlikely that this will have an impact on the outcome of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- Test has been performed 1991, before the regulation has been revised with respect to deviation from the LLNA as "gold standard"
Test material
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-aminoethoxy)ethan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Buckberg Lab Animals, Tomkins Cove, New York
- Weight at study initiation: 300-700g
- Housing: individually in stainless steel wire mesh cages
- Diet (e.g. ad libitum): purina guinea pig diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: Jan 1991 To: March 1991
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
- Day(s)/duration:
- 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
- Day(s)/duration:
- 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- other: no data
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
- Day(s)/duration:
- 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
- Day(s)/duration:
- 29
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 %
- Day(s)/duration:
- 36
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- dose range: 8 or 10 (unclear)
test article: 20 (10 male, 10 female)
positive control: 5
negative control: 10 - Details on study design:
- RANGE FINDING TESTS:
10 unexposed animals (5male/5female) are exposed to 4 different concentrations of the test material: 80% ethanol as the vehicle.
primary challenge responses were graded
Highest non-irritatting concentration = concentration that induced responses not exceeding 2 + and 2 0 grades in the group of 4 animals.
the dose chosen for induction, challenge and rechallenge : 10%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 (3 inductions, 1challenge, 1 rechallenge)
- Exposure period: -
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only (80% ethanol)
- Site: L shoulder
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 28 (or 29) and 35 (or 36) (unclear)
- Exposure period: -
- Test groups: test substance in vehicle
- Control group: vehicle only (left flank), test article (right flank)
- Site: naive site on left side
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48h
OTHER: 24h after challenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New York). A minimum of 2h after depilation test sites were graded. The grading was repeated 24h later (48h grade). - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- Sensitising effects are observed in all 5 animals of the positive control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.3
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.2
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.3
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3 % DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Severity: 3.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3 % DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Severity: 2.6
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 % acetone
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 % acetone
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- challenged with 10% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- challenged with 10% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Severity: 0.2
Any other information on results incl. tables
Primary challenges were carried out after 14 days, 1 positive response was observed after 24 and 48 hours in the 10% DGA group. 7 days after the primary challenge, all test article treated animals were rechallenged at 10% concentration. 2 positive responses were observed after 24 and 48 hours after this rechallenge. After initial challenge a positive response was observed in all animals receiving the DNCB positive control. Erythema observed at 24 and 48 hours in 3 of negative control group at initial challenge.
Under EU
criteria, the product is not classed as a sensitizer as it indicates a
maximum (at rechallenge) of 10% positive (2/20) responses. A minimum
figure of 15% under any study would be necessary for classification as a
sensitizer with R43 under EU 18th ATP of the DSD. Practical experience
over 20 years of manufacturing this product adds weight to this
conclusion.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was determined to be not skin sensitizing in a Buehler test.
- Executive summary:
In two preliminary dose-range-finding studies, ten animals (five males and five females) were each exposed to four different concentrations of the test substance in either 80% ethanol or acetone, to determine the highest non-irritating dose.
Based upon the results of the dose-range-finding studies, the test article was dosed at a 10% concentration. In order to determine if the test article is capable of causing delayed contact hypersensitivity, the test substance, was dermally applied to twenty guinea pigs (ten males and ten females) for a total of three six hour insult periods. Another group of five guinea pigs (three males and two females) was treated with 1-chloro-2,4-dinitrobenzene at a 0.3% concentration for a total of three six-hour insult periods. An additional group of ten guinea pigs (five males and five females) was treated with vehicle (80% ethanol) for a total of three six-hour insult periods. Fourteen days after the last induction period, all animals were challenged at a naive site.
A positive response was elicited in the animals receiving the positive control article, 1-chloro- 2, 4-dinitrobenzene (DNCB). Slight patchy erythema was observed at 24 and 48 hours in three of the negative control animals challenged with the test article at a 10% concentration. One positive response was observed at 24 and 48 hours after challenge in the test article-treated group. No responses were observed in the negative control animals challenged with the vehicle (acetone).
Seven days following the primary challenge, all test article treated animals were rechallenged at a naive site at a 10% concentration. Two positive responses were observed at 24 and 48 hours after rechallenge.
Based upon the observations made in the Delayed Contact Hypersensitivity Study in Guinea Pigs, the test substance induced, challenged and rechallenged at a 10% concentration did not cause delayed contact hypersensitivity in guinea pigs.
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.
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