Registration Dossier
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EC number: 701-216-4 | CAS number: -
- 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
In a skin irritation study conducted to OECD 404 and GLP (Springborn Laboratories, 2000) DTPMP-xNa was very mildly irritating to the skin of rabbits.
In an eye irritation study conducted to OECD 405 and GLP (Springborn Laboratories, 2000b) DTPMP-xNa was not irritating to the eyes of rabbits.
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:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Method: other: Protocol number L-58081-R013. Insufficient detail presented to assess comparability with guideline.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data - Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- other: aqueous solution, administered undiluted.
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml. Although the recommended dose of 0.5 ml was achieved for the formulation, this means that the limit dose for the active salt was not attained. The level of irritation of the anhydrous active salt may therefore be underestimated by this study. - Duration of treatment / exposure:
- no data
- Observation period:
- 72 hours
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
SCORING SYSTEM: No data (assumed to be Draize) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hour
- Score:
- 0.4
- Max. score:
- 8
- Reversibility:
- other: Essentially reversible in 72 hours
- Remarks on result:
- other: Based on combined intact and abraded skin.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Intact skin: 24 hours after the end of exposure 1/6 rabbits had grade 1 erythema, which reversed by 72 hours. There was no oedema in any of the animals.
Abraded skin: 24 hours after the end of exposure 4/6 rabbits had grade 1 erythema, which remained in only one animal by 72 hours. There was no oedema in any of the animals. - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a pre-GLP skin irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines, and available in summary only, Dequest 2060 was slightly irritating to rabbit skin.
- Executive summary:
In a pre-GLP skin irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines, and available in summary only, 0.5 ml undiluted Dequest 2060 was applied to the intact and abraded skin of six New Zealand white rabbits (duration not given). After removal of dressings, skin reactions were graded (scoring system not given) at 24 and 72 hours. 24 hours after the end of exposure to intact skin, 1/6 rabbits had grade 1 erythema, which reversed by 72 hours. For abraded skin, 4/6 rabbits had grade 1 erythema 24 hours after the end of exposure, which remained in only one animal by 72 hours. There was no oedema in any of the animals. Dequest was therefore only slightly irritating to the skin of rabbits.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.07.1982 to 30.07.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- aqueous solution, administered undiluted.
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- Three
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: No signs of irritation observed in any animal.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study conducted according to OECD 404 and to GLP (reliability score 1), Briquest 543-33S (DTPMP sodium salt) was not irritating to the skin of rabbits.
Referenceopen allclose all
Group total (intact skin) = 1, group total (abraded skin) = 5
PDII = 6/24 = 0.25
No skin reactions were present in any of the six animals at 1hr, 24hr, 48hr and 72hr following removal of the patch.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.08.1982 to 27.08.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- aqueous solution, administered undiluted.
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Comment: other: No indication that eye was rinsed.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance produced no evidence of an ocular irritation in any rabbit. A dulling of the normal lustre of the cornea was observed in all three rabbits at the one hour reading, accompanied in one rabbit by iritis. A diffuse crimson-red colouration of the conjunctivae accompanied by slight or distinct swelling with partial eversion of the eyelids was observed in two rabbits at this reading. Mild conjunctival inflammation and swelling was observed in the remaining animal. The reactons had reversed in all three animals by the 24 hour reading.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study conducted to OECD 405 and GLP (reliability score 1) Briquest 543-33S (sodium salt of DTPMP) was not irritating to the eyes of rabbits.
Reference
CORNEA
No scored effects, but dulling of the cornea was observed in
all 3 animals, 1 hour after dosing. Total score 0.
IRIS
Score 1 in 1 animal, 1 hour after dosing. Total score 1.
CONJUCTIVAL REDNESS
Score 2 in 2 animals and score 1 in the third, 1 hour after
dosing. Total score 5.
CONJUNCTIVAL CHEMOSIS
Score 2 in 1 animal and score 1 in 2 animals, 1 hour after
dosing. Total score 4.
From 24 hours after dosing, no abnormal symptoms observed
any animal.
Group total score = 10.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The most reliable studies were selected as the key studies. The supporting studies also show the sodium salts of DTPMP are, at most, mildly irritating to the skin and eyes of rabbits.
Justification for classification or non-classification
The classification decisions for skin and eye irritation for the DTPMP salts are dependent on the ionisation state and conclusions are based on experimental evidence in the key skin and eyes studies in rabbits. Therefore, based on this information, no classification is required for DTPMP (5-7Na) according to Regulation (EC) No 1272/2008.
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