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EC number: 235-979-5 | CAS number: 13078-36-9
- 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
Using a read-across extrapolation approach from OECD 404 and 405 guideline studies on the structural analogue DTPA pentasodium salt, DTPA trisodium salt is predicted to be of very mild skin irritancy and slight ocular irritancy. The read-across is supported by the close structural similarity of the two substances and the neutral, as opposed to alkaline, pH of DTPA trisodium salt.
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:
- ca. 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No data on batch number and composition; basic data given, comparable to guidelines/standards (max reliability score can be 2)
- Justification for type of information:
- The source substance (DTPA 5Na) and the target substance (DTPA 3Na) are the pentasodium and trisodium salts of the same organic acid and are therefore structurally very similar. The purity/impurity profile for the source material is not characterised (40% solution as supplied) in the acute dermal irritancy robust study summary, but since the target material is > 99.9% pure and contains no detectable impurities, the extrapolation of acute irritant properties from the source material to the target material is considered valid, particularly in view of the very conservative extrapolation resulting from the significant difference in pH between the two substances (12.52 for DTPA 5Na and 7.5 for DTPA 3Na). The source material acute dermal irritation study was conducted according to OECD test guideline 404 and is considered reliable with restrictions (Category 2).
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack of detail on test material (batch number and composition) and age/source of animals. Number of air changes also not mentioned
- Principles of method if other than guideline:
- Method used described in 'Appraisal of the safety of chemicals in foods, drugs and cosmetics', by the staff of the division of
pharmacology, food and drug administration. Primary irritation score by J.H. Draize (1959).
Test substance was also tested on abraded skin. - GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not indicated
- Age at study initiation: not indicated
- Weight at study initiation: 2.4-2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: not indicated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 45-55
- Air changes (per hr): not indicated.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not indicated. - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and one side also abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- up to 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: on the back
- % coverage: two squares of 2.5 cm
- Type of wrap if used: patches consisted of double layer light gauze; the trunks was wrapped in a rubber sleeve and the animals were immobilized in restrainers
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize (1959). Readings were made immediately after removal of the patches, and 24 and 72
hours thereafter. The cumulative scores 4/24 hours and 72 hours (erythema and oedema) were averaged for bot abraded and
intact skin and added together to calculate the primary irritation index. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4/24 hours and 72 hours
- Score:
- 0
- Reversibility:
- other: no irritation at all
- Remarks on result:
- other: all 3 animals had score: 0
- Irritant / corrosive response data:
- No irritation
- Other effects:
- Not indicated
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not a skin irritant
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used was essentially according to the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irri tation/Corrosion" A single 4 -hour, occluded application of the test material to intact and abraded skin of three rabbits produced no erythema or oedema. All treated skin sites appeared normal at the 4/24 -hour and 72 -hour observation. The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to OECD-GHS labeling regulations. No symbol and risk phrase are required.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The source substance (DTPA 5Na) and the target substance (DTPA 3Na) are the penta-sodium and tri-sodium salts of the same organic acid and are therefore structurally very similar. They are of comparable high water solubility and DTPA pentasodium salt is alkaline and DTPA trisodium salt neutral pH in aqueous solution (12.52 for DTPA 5Na and 7.5 for DTPA 3Na). Extrapolation of irritancy potential from the source substance to the target substance is therefore considered valid as a 'worst case' scenario.
- Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- > 99% purity
- Species:
- rabbit
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Conclusions:
- DTPA trisodium salt is predicted to be non-irritant to skin.
- Executive summary:
Using a read-across approach from an OECD 404 guideline study on the structural analogue DTPA pentasodium salt, DTPA trisodium salt is predicted to be of very mild skin irritancy. The read-across is supported by the close structural similarity of the two substances and the neutral, as opposed to alkaline, pH of DTPA trisodium salt.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well-documented publication which meets basic scientific principles
- Justification for type of information:
- The source substance (DTPA 5Na) and the target substance (DTPA 3Na) are the pentasodium and trisodium salts of the same organic acid and are therefore structurally very similar. The purity/impurity profile for the source material is not characterised (40% solution as supplied) in the acute eye irritancy robust study summary, but since the target material is > 99.9% pure and contains no detectable impurities, the extrapolation of acute irritant properties from the source material to the target material is considered valid, particularly in view of the very conservative extrapolation resulting from the significant difference in pH between the two substances (12.52 for DTPA 5Na and 7.5 for DTPA 3Na). The source material eye irritation study was conducted according to OECD test guideline 405 and is considered reliable with restrictions (Category 2).
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Housing: single housing per stainless steel cage (area about 40 x 51 cm)
- Diet (e.g. ad libitum): Ovator Solikanin, Duesseldorf, Germany
- Water (e.g. ad libitum): tap wter (about 250 ml per animal)
- Acclimation period: 8 days before starting the experiment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The acclimatization period was 8 days before starting the study; same housing conditions as during the testing period. Application site: conjunctival sac of the right eye. Observations were made 1 h, 24 h, 48 h, 72 h and 8 days after application. The test substance was not rinsed out.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 6
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 4
- Max. score:
- 6
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3
- Max. score:
- 5
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The source substance (DTPA 5Na) and the target substance (DTPA 3Na) are the penta-sodium and tri-sodium salts of the same organic acid and are therefore structurally very similar. They are of comparable high water solubility and DTPA trisodium salt is neutral and DTPA pentasodium salt alkaline in aqueous solution (7.5 for DTPA 3Na and 12.52 for DTPA 5Na). Extrapolation of irritancy potential from the source material to the target substance is therefore considered valid as a 'worst case' scenario,
- Reason / purpose for cross-reference:
- read-across: supporting information
- Specific details on test material used for the study:
- > 99% purity
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Conclusions:
- DTPA trisodium salt is predicted to be slightly irritant to eyes. .
- Executive summary:
Using a read-across extrapolation approach from an OECD 405 guideline study on the structural analogue DTPA pentasodium salt, DTPA trisodium salt is predicted to be slightly irritant to eyes. The read-across is supported by the close structural similarity of the two substances and the neutral, as opposed to alkaline, pH of DTPA trisodium salt.
Referenceopen allclose all
Observations after | Animal No. | Cornea | Iris | Conjunctiva | Single irritation score | ||||
Cloudiness | Area | Reddening | Swelling | Secretion | |||||
24 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
2 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | ||
3 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | ||
Mean | 6 | ||||||||
48 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
2 | 0 | 0 | 0 | 2 | 0 | 1 | 6 | ||
3 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | ||
Mean | 4 | ||||||||
72 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
2 | 0 | 0 | 0 | 2 | 0 | 1 | 6 | ||
3 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | ||
Mean | 3 | ||||||||
8 days | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Mean | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute dermal irritancy of DTPA pentasodium salt is very mild, with no erythematous or oedematous reactions elicited in abraded or non-abraded rabbit skin (OECD 404). DTPA penta and trisodium salts are structurally similar, and DTPA pentasodium salt is alkaline and DTPA trisodium salt neutral in aqueous solution. Based on a read-across approach, DTPA trisodium salt is therefore predicted to be very mildly irritant to skin.
DTPA pentasodium salt elicits slight eye irritation, with transient conjunctival erythema and oedema in rabbits (OECD 405). DTPA pentasodium salt is structurally similar to DTPA trisodium salt, but has an alkaline pH in aqueous solution, whereas DTPA trisodium salt is neutral. Based on a 'worst case' read-across approach, DTPA trisodium salt is predicted to be of slight ocular irritancy.
Justification for classification or non-classification
DTPA trisodium salt is considered not to meet the CLP criteria for classification for acute skin or eye irritation.
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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