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EC number: 239-717-0 | CAS number: 15647-11-7
- 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
There is reliable information available from skin irritation and eye irritation studies (Reprotox 1980). Data give indication that the substance is corrosive to skin.
Strong reactions to eyes causes eye damage (Reprotox 1980).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Principles of method if other than guideline:
- Method: U.S. Consumer Product Safety Commission, Code of Federal Regulations, Title 16, Section 1500.41; Evaluation with Draize scores.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: New Zealand white
- Source: J. Scheele, Büderich/Westf., 4760 Werl
Housing conditions:
- Room temperature: 20°C (+/- 1°C);
- Light: 12 hours/day;
- Access to drinking water: ad libitum;
- Diet: K4 diet for rabbits (Ssniff; Soest) - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, intact and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amound applied: 0.5 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- Postexposure period: 14 days
- Number of animals:
- 6
- Details on study design:
- ADMINISTRATION:
- Volume administered or concentration: 0.5 ml
- Post dose observation period: 48 hours
- Application to both intact and scarified skin
EXAMINATIONS: 24 and 72 hours - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h and 72 h
- Score:
- 2.25
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- necrosis, strong incrustion
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 h and 72 h
- Score:
- 3.6
- Max. score:
- 8
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 2.25
- Edema: 1.33
24 hours after application all rabbits showed necrosis and slight to moderate oedem, 72 hours after application all rabbits showed strong incrustions - Other effects:
- no
- Conclusions:
- Under the present conditions of this study necrosis, strong incrustions and slight to moderate oedema were observed after application of 0.5 ml itest tem (24 hrs exposure) to both intact and sacrified skin of rabbits. Therfore, test item is strong irritating to skin.
- Executive summary:
The acute skin irritation properties of the test item were estimated in a modified Draize test. A dose of 0.5 ml test item per animal was applied to both intact and sacrified skin of 6 rabbits under occlusive conditions. After a 24 -hours exposure period the patch was removed and skin irritation was assessed using Draize scale. The average scores at 24 and 72 hours after patch removal are as follows:
- Erythema: 2.25
- Edema: 1.33
24 hours after application all rabbits showed necrosis and slight to moderate oedem, 72 hours after application all rabbits showed strong incrustions.
Therfore, test item is strong irritating to skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
no further remarks
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods
- Principles of method if other than guideline:
- Method: other: Draize Test according to Consumer Product Safety Commission (U.S.), Code of Federal Regulations, Title 16, Section 1500.42;
Evaluation with Draize scores - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: New Zealand white
- Source: J. Scheele, Büderich/Westf., 4760 Werl
Housing conditions:
- Room temperature: 20°C (+/- 1°C);
- Light: 12 hours/day;
- Access to drinking water: ad libitum;
- Diet: K4 diet for rabbits (Ssniff; Soest) - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- not rinsed
no removal of test substance - Observation period (in vivo):
- Ophthalmoscopic examination after 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
Scoring system: Draize (1959) - Irritation parameter:
- other: Very strong reactions after 24h observation so that all animals were killed
- Remarks:
- Based on very strong reactions a score could not determined.
- Time point:
- 24 h
- Score:
- 20
- Max. score:
- 20
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Conclusions:
- Under conditions of the study test item showed necrosis effects to rabbit eyes. Due to the severe damage of the eyes, rabbits were euthanized 24 after application.
- Executive summary:
The acute eye irritation properties of the test item were estimated in a Draize test. An amount of 0.1 ml of the undiluted test substance was instilled into one eye of each of six albino rabbits, and the untreated eye served as control. The eyes are not washed following instillation of test material.
24 hours after application all animals showed necrosis effects on the eyes. Due to the severe damage of the eyes, rabbits were euthanized 24 after application.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
no further remarks
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test data on skin irritation alone do not allow to conclude a subcategory concerning corrosive effects. The corresponding Diamine (Isophorone diamine (IPD) (2855-13-2) is classified with category 1B corrosive. As a weight of evidence approach (WoE)it can be concluded that IPAA induces worst case effects similar to IPD. Therefore, IPAA is classified with category 1B of hazard class skin corrosion/irritation.
The test data concerning evaluation of eye damage/irritation show that a classification with category 1 is necessary.
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