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EC number: 205-411-0 | CAS number: 140-31-8
- 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
Endpoint summary
Administrative data
Description of key information
Aminoethyl piperazine was positive in two guinea pig maximization tests
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2e: Meets generally accepted scientific standards, well-documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- study examined sensitization capability of structurally similar amines
- Principles of method if other than guideline:
- Magnusson, B. and Kligman, A.M.: The identification of contact allergens by animal assay. The guinea pig maximization test. J. Invest. Dermatol. 52:268, 1969
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid guinea pig maximisation test is available and therefore no in vitro test is necessary
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Dunkin Hartley Haz:(DH)fBR albino guinea pigs (5-7 weeks old, 278-444 gr) were obtained from HRP Inc. (Denver, PA).
- Route:
- intradermal
- Vehicle:
- water
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- No. of animals per dose:
- 10/sex
- Details on study design:
- A range-finding study was conducted to select appropriate concentrations for the intradermal and epicutaneous procedures. Animals were inspected 24 and 48 hr after dosing for signs of necrosis and ulceration.
In the definitive sensitization test, groups of 10 male and 10 female guinea pigs each received 0.1 ml intradermal induction injections into 2 sites of the clipped shoulder skin as follows: 50% (v/v) Freund's complete adjuvant (FCA) water emulsion, the test material or vehicle, and the test material in FCA/water emulsion or FCA/water emulsion. Epicutaneous inductions were conducted 7 days later. The test material was applied to saturation ((0.2 ml) to a 2 x 4 cm filter paper, which was then placed on the test site and secured with tape. The patches were left in place for 48 hr, after which they were removed and the skin wiped free of any excess test material. Epicutaneous challenge was undertaken by applying 2 x 2 cm filter paper squares soaked in the appropriate concentration of the test material to a previously untreated site (right flank) 14 days after epicutaneous induction (i.e., 21 days from the start of the study). Patches were left in place for 24 hr, and the sites inspected for signs of irritation 24-48 hr after removal of the occlusive dressings.
Seven days after the challenge exposure(i.e., 28 days from the start of the study), the cross-challenge treatment was administered. Test materials were administered to the clipped skin in a similar manner as in the challenge phase but at previously untreated sites (left flank). Smaller patches (0.825 in2 adhesive bandages) were used in order to allow all of the test materials to fit on the test site. Materials were applied to saturation (0.03 ml per patch). Patches were left in place for 24 hr and the sites inspected for signs of irritation 24-48 hr after removal of the occlusive dressings. - Challenge controls:
- Irritation control animals, five male and five female guinea pigs, received the same challenge procedures as in the definitive sensitization study, but did not have preceding intradermal and/or epicutaneous induction procedures. This allowed differentiation between primary skin irritation due to the test material, and those produced by a hypersensitivity reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Clear dermal responses (scores of 1 or higher) 24 and/or 48 hours after challenge; six additional animals exhibited scores of 0.5 at one or both intervals. Based on clear responses in five of the twenty animals (25%)' A
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- other: Results not reported
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Positive in guinea pig maximization test.
Positive results were also obtained in a cross challenge with several structurally similar alkyleneamines. - Executive summary:
The dermal sensitization potential was examined in the Guinea Pig Maximization Assay with aminoethylpiperazine (AEP). Cross-reactivity was also examined with structurally similar ethyleneamines. In this assay, AEP was positive and was shown to produce positive results when cross challenged with several structurally similar alkyleneamines.
Reference
Based on the
probe study, the maximum concentrations used were 5% for the intradermal
induction, 50% for epicutaneous induction and 25% for epicutaneous
challenge phases.
In the definitive study, five of 20 guinea pigs had a positive response.
In the cross-reaction phase, animals induced with 50% demonstrated a
greater response with diethylenetriamine (55%),
hydroxyethylethylenediamine (75%), triethylenetetramine (45%) and
piperazine (30%). Less
of a response was observed in animals treated with ethylenediamine and
tetraethylenepentamine (0 and 5% responded positive, respectively).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Concentrations of AEP were base on a probe study. The maximum concentration used were 5% for the intradermal induction , 50% for epicutaneous induction and 25% for epicutaneous challenges phases. Five of 20 guinea pigs had a positive response. Cross reactions were also observed when challenged with other alkyleneamines.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Since these are positive results from animal studies as a skin sensitizer, aminoethyl piperazine is classified as a GHS Category 1.
There is no data on respiratory sensitisation or how skin sensitising potential may relate to respiratory sensitising potential. Therefore, it is not possible to comment on whether this compound would also be a respiratory sensitiser.
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