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EC number: 215-851-5 | CAS number: 1429-50-1
- 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
An acute oral toxicity LD50 of 6900 mg/kg is reported in a report which was carried out according to a protocol similar to guideline but which pre-dated GLP (Younger Laboratories 1968). The sample was fed as a 25% solution-suspension in corn oil at 5010, 6310, 7940 and 10000 mg/kg, with necropsy findings of inflammation of the gastric mucosa and liver hyperemia.
A reliable acute inhalation study conducted according to a protocol equivalent to current guideline reports an LC50 value of 4.60 mg/l (3.78-5.17 mg/l) of dust (Biodynamics 1980). The study was not compliant with GLP.
An acute dermal LD50 value of >5010 mg/kg was reported in a study which was conducted according to an appropriate test protocol, but which pre-dated GLP. No real symptoms of acute toxicity were noted (Younger Laboratories 1968). The test material was administered as a 25% solution in corn oil at 501, 794, 1260, 2000, 3160, 5010 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Principles of method if other than guideline:
- After the approximate Minimum Lethal Dose was determined, groups of male and female rats were fed in increasing doses at increments of 0.1 fractional log intervals at four levels designed to blanket the toxicity range thereby supplying data for calculation of the LD50. The length of the observation period was not specified.
- GLP compliance:
- no
- Test type:
- other:
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data.
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Sample fed as a 25% solution-suspension in corn oil - Doses:
- 5010, 6310, 7940, 10000 mg/kg
- No. of animals per sex per dose:
- 3+2 M/F per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: not specified
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: not specified
. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 900 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 6070-7865 mg/kg
- Mortality:
- See table 1. Survival time was 4 hours to approximately 24 hours.
- Clinical signs:
- other: Toxic symptoms included diarrhea, loss of appetite and increasing weakness.
- Gross pathology:
- At autopsy, there was inflammation of the gastric mucosa in addition to liver hyperemia.
- Other findings:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute oral toxicity LD50 of 6900 mg/kg is reported in a report which was carried out according to a protocol similar to guideline but not in compliance with GLP.
Reference
Table 1: Number of animals dead and time range within which mortality occurred
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
||
Male |
Female |
Combined |
||
5010 |
0/2 |
0/3 |
0/5 |
|
6310 |
1/3 |
1/2 |
3/5 |
4-24h |
7940 |
2/3 |
2/2 |
4/5 |
4-24h |
10000 |
3/3 |
2/2 |
5/5 |
4-24h |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 900 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: River Breeding Laboratories, Wilmington, Massachusetts
- Animal weight: 239-263g (males), 218-240g (females) - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Wright Dust Feed cylinders using a carver hydraulic press
- Exposure chamber volume: 26.5 litre chamber
- Source and rate of air: 15 litres / minute
- System of generating particulates/aerosols: The test material was sieved through a #60 mesh sieve and packed into the Wright Dust cylinders using the Carver hydraulic press operating at 200 pounds per square inch. Dry air was passed through a modified Wright Dust Feed generator with a specially machined cutting blade to generate a dust laden atmosphere.
TEST ATMOSPHERE
- Brief description of analytical method used: The cylinders, cutting blade and nozzle were weighed before and after the exposure. The difference in weight represented the total amount of test material delievered into the test chamber; this divided by the total volume of air delivered yielded the nominal exposure concentration. Air samples were withdrawn each hour for gravimetric determination of the airborne concentration; these samples were withdrawn for determination of the particle size distribution using castella Cascade Impactor.
- Samples taken from breathing zone: yes
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.7 microns / 2-2.7 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 4.60 mg/l (3.78-5.17 mg/l) i.e. approximately 30% of the nominal value which was 15.5 mg/l
- No. of animals per sex per dose:
- 5M, 5F
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for abnormal signs before exposure, every 15 minutes for first hour, hourly thereafter, upon removal from the chamber hourly for four hours post-exposure and daily thereafter for 14 days. Individual body weights for all rats were recorded on day 0 (prior to exposure) and on days 1,2,4,7 and 14.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.6 mg/L air (analytical)
- Based on:
- test mat.
- Remarks on result:
- other: dust
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: Beginning ca. 15 minutes after initiation of exposure: hypoactivity, salivation, red nasal discharge, swollen eyelids, lacrimation, rapid or laboured respiration and soft stool were observed. Due to the density of the dust cloud visibility of the animals
- Body weight:
- Transient body weight losses were seen in most rats but in most cases these had recovered to the starting weights by day 4 or 7. Weight gains in the second week were within the range of normal expectation.
- Gross pathology:
- At necropsy lung discolouration was seen in all males and two females. These are common macropathological entities in this strain of rat but the incidence in males may reflect a slight response to treatment, especially if viewed in conjunction with the in vivo evidence of irritant effects on the ocular, buccal, nasal and respiratory mucosae on the day of exposure.
- Other findings:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An LC50 value of 4.60 mg/l (3.78-5.17 mg/l) i.e. approximately 30% of the nominal value which was 15.5 mg/l is reported in a reliable study conducted according to a protocol equivalent to current guideline. The study was not compliant with GLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 600 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The number of animals tested per dose was one.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Similar to version adopted in 1987
- Principles of method if other than guideline:
- The diluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the skin of the rabbits. Only one rabbit was tested per dose.
- GLP compliance:
- no
- Test type:
- other:
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individual cages - Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- No data.
- Duration of exposure:
- 24 hours
- Doses:
- 25% solution in corn oil at 501, 794, 1260, 2000, 3160, 5010 mg/kg
- No. of animals per sex per dose:
- 1 animal per dose, either male or female.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: no data
- Necropsy of survivors performed: no - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 010 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: No real symptoms of acute toxicity were noted. Weakness was at a minimum and there was no nervousness.
- Gross pathology:
- No necropsy.
- Other findings:
- None reported.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- An acute dermal LD50 value of >5010 mg/kg was reported in a study which was conducted according to an appropriate test protocol, but not in compliance with GLP.
Reference
The compound was not absorbed to any great extent.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 010 mg/kg bw
Additional information
The most recent and reliable studies were selected as key. The available supporting studies are concurrent with the key studies,
and support the low acute toxicity of EDTMP-H (CAS 1429-50-1).
Although the final LC50 of the acute inhalation toxicity study to dust exposure is determined to be >4.6 mg/l which is below the threshold value for classification, the range (3.78-5.17 mg/l) from which the mean was derived, the lack of mortalities and the overall results of the acute toxicity endpoints indicate low acute toxicity of the test material.
Justification for classification or non-classification
Based on the available information, no classification is required for acute toxicity for EDTMP acid according to Regulation (EC) No. 1272/2008.
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