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EC number: 241-304-5 | CAS number: 17268-47-2
- 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
Skin Irritation
Severe erythema, moderate to severe edema, necrosis on 6 of 6 rabbits from 0.5 ml; ulceration, scabs also apparent; irritation Dersisted through 14 days. Corrosive to skin.
Eye Irritations
Persistent, minor, diffuse corneal opacity in 6 of 6 eyes, iritis in 6, moderate to severe conjunctival irritation in 6 from 0.005 ml; conjunctival necrosis, instances of corneal vascularization observed; 3 healed, 3 still injured at 21 days.
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:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand White rabbits, weighing between 2.0 and 3.0 kg,
The animals are maintained on appropriate commercial diet and municipal water. Both are available ad libitum expect during periods of manipulation. Animal weights are recorded at 0 days (before dose), 7 days and 14 days (just prior sacrifice). At death or sacrifice, each animal is subjected to gross pathological evaluation. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- Male or female New Zealand White rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period.
Excess sample is removed after contact. Skin reaction is scored, by the method of Draize, at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3.2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not specified
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Skin Irritation, Rabbit (4-hr occluded)
Severe erythema, moderate to severe edema, necrosis on 6 of 6 rabbits from 0.5 ml; ulceration, scabs also apparent; irritation persisted through 14 days. Corrosive to skin.
Reference
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:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male or female Hew Zealand White rabbits
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid).
- Duration of treatment / exposure:
- One application
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored by the attached system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- not specified
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Persistent, minor, diffuse corneal opacity in 6 of 6 eyes, iritis in 6, moderate to severe conjunctival irritation in 6 from 0.005 ml; conjunctival necrosis, instances of corneal vascularization observed; 3 healed, 3 still injured at 21 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Skin Irritation:
Category 1 (skin corrosion) =
Destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure equal to 4 h
Note: This category is further subdivided in three sub-categories (1A, 1B, 1C). Corrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation. When data are sufficient, substances shall be classified in one of the three sub-categories 1A, 1B, or 1C.
6 of 6 animals demonstrated scores of 4 at 4 hours. The study report does not include information on irritation at under 4 hours therefore sub catagorisation cannot be applied.bTherefore DDPA is considered a Category 1 skin irritant.
Eye Irritation:
Category 2 =
Substances that produce in at least in 2 of 3 tested animals, a positive response of:
(a) corneal opacity = 1 and/or
(b) iritis = 1, and/or
(c) conjunctival redness = 2 and/or
(d) conjunctival oedema (chemosis) = 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
6 out of 6 animals demonstrated a score of 1 (corneal opacity) at 24, 48 and 72 hours. Therefore DDPA is considered a Category 2 eye irritant.
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