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Diss Factsheets
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EC number: 203-049-8 | CAS number: 102-71-6
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.09-21.10.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
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-[bis(2-hydroxyethyl)amino]ethan-1-ol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sample 838, B 255 A (03.06.1988)
- Purity test date: 14.07.1988
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 20°C
- Stability under test conditions: in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Strain: Hoe: DHPK(SPFLac)
- Weight at study initiation: x = 313g (=100 %); xmin= 286g (- 8,6%); * xmax= 337g (+ 7,7%); n = 15
- Housing: 5/ cage
- Diet: ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 2 % dermal induction: unchanged dermal challenge: 10 %
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 2 % dermal induction: unchanged dermal challenge: 10 %
- No. of animals per dose:
- pretest: 6 (determination of the non-irritating concentration determination of the intradermal tolerance: 3 control group 1: 5 control group 2: 5 treatment group: 10
- Details on study design:
- RANGE FINDING TESTS: (dermal occlusive on the flank skin): 100%, 10% and 1% in salineThe animal's fur was clipped and 0.5 mL of the test substance was applied on a patch that was fixed on the skin under occlusive condition for 24 hours. After 24 hours the patch was removed and the skin was assessed another 24 hours later for erythema and oedema reactions.To study the intradermal tolerance of the test substance, the substance was injected in concentrations of 0.2 %, 1 % and 5 % intradermally in the skin of the back, each concentration at two seperate areas.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal) and 1 epicutaneous- Exposure period: 48 hours (epicutaneous)
- Test groups: 2x 0.1 mL at a concentration of 2 % in 50% Freunds adjuvans; 2x 0.1 mL at a concentration of 2 % in NaCl 0.9 %; 2x 0.1 mL of 50% Freunds adjuvans (intradermal) 0.5 mL of the test substance or vehicle was applied on a 2 x 4 cm patch which was applied for 48 hours to the animal's skin under occlusive conditions
- Control group: 2x 0.1 mL of 50% Freunds adjuvans; 2x 0.1 mL NaCl 0.9 %; 2x 0.1 mL of 50% Freunds adjuvans (intradermal- Site: skin of the back
B. CHALLENGE EXPOSURE
- No. of exposures: 1- Test groups: 0.5 mL of the 10 % test substance or vehicle was applied on a 2 x 2 cm patch which was applied for 24 hours to the animal's skin under occlusive conditions
- Control group: 0.5 mL of the 10 % test substance in saline
- Site: flank skin- Evaluation (hr after challenge): 48 hours, 72 hours
OTHER: Time scale:
day 0: determination of body weight
day 1: intradermal induction
day 9: dermal induction
day 11: evaluation of skin irritation
day 22: dermal challenge
day 23: removal of occlusive dressing
day 24: 1st evaluation
day 25: 2nd evaluation
Scoring:equivalent to Draize scores - Challenge controls:
- yes
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Body weight development:
mean body weight gain:
control group: 30.8 %
Treatment group: 35.7 %
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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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