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EC number: 218-542-3 | CAS number: 2177-70-0
- 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
Oral LD50 (rate, female) = 500 mg/kg bw; OECD guideline 423; GLP
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
- Study period:
- 2012-03-20 to 2012-04-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Wistar (RccHan™:WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 151-164 g
- Fasting period before study: yes, overnight + 3-4 h after dosing
- Housing: in groups of 3, in suspended solid-floor polypropylene cages furnished with with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min. 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: 2000 mg/kg bw: unchanged; 300 mg/kg bw: arachis oil BP
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/kg bw dose group: 30 mg/mL
- Amount of vehicle (if gavage): 300 mg/kg bw dose group: 10 mL/kg bw, 2000 mg/kg bw dose group: dosed unchanged, dose volume 1.19 mL/kg bw;
- Justification for choice of vehicle: the test item did not dissolve/suspend in distilled water
CLASS METHOD
- Rationale for the selection of the starting dose: In absence of data regarding the toxicity of the test item, 300 mg/kg bw was chosen as starting dose. - Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- A group of three fasted females was treated with the test item at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at dose levels of 300 and 2000 mg/kg bodyweight. Dosing was performed sequentially.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded on days 0, 7, 14, or at death; clinical signs: 1/2, 1, 2, 4 h after dosing, once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy of dead animals - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- All animals of the 2000 mg/kg bw dose group were killed for humane reasons 1 h after dosing, due to occurrence of severe clinical signs of toxicity.
There were no deaths at a dose level of 300 mg/kg bw. - Clinical signs:
- other: 2000 mg/kg bw: body tremors, prostration, ptosis, loss of righting reflex, laboured/noisy respiration 300 mg/kg bw: 2/6 animals: no signs of systemic toxicity 4/6 animals: ataxia, lethargy and/or hunched posture
- Gross pathology:
- No abnormalities were observed in animals treated with 300 mg/kg bw .
Clear liquid present in the stomach and epithelial sloughing of the gastric mucosa were noted at necropsy of animals treated with 2000 mg/kg bw. - Interpretation of results:
- other: Category 4
- Remarks:
- Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The acute oral LD50 of PHMA in female rats is ca. 500 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423 (adopted 17 December 2001), groups of fasted, 8-12 weeks old, Wistar strain rats (3 females) were given a single oral dose of PHMA at doses of 300 and 2000 mg/kg bw and observed for 14 days. A group of three fasted females was treated with the test item at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at dose levels of 300 and 2000 mg/kg bodyweight. Dosing was performed sequentially.
There were no deaths at a dose level of 300 mg/kg bw. All animals of the 2000 mg/kg bw dose group were killed for humane reasons 1 h after dosing, due to occurrence of severe clinical signs of toxicity (body tremors, prostration, ptosis, loss of righting reflex, laboured/noisy respiration). In the 300 mg/kg bw dose groups 2/6 animals showed no signs of systemic toxicity; in 4/6 animals ataxia,lethargy and/or hunched posture was observed.
The surviving animals showed the expected body weight gains.
No abnormalities were observed at necropsy in animals of the 300 mg/kg bw dose group. Clear liquid present in the stomach and epithelial sloughing of the gastric mucosa were noted at necropsy of animals treated with 2000 mg/kg bw.
Oral LD50 Female rats: according to Annex 2c of OECD Guideline 423, LD50 value of 500 mg/kg bw was estimated
Reference
According to Annex 2c of OECD Guideline 423, LD50 value of 500 mg/kg bw was estimated.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- One relevant, reliable (Klimisch score = 1) and adequate study is available.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One reliable (RL=1), relevant and adequate study is available to assess the acute oral toxicity of PHMA:
In an acute oral toxicity study according to OECD guideline 423 (adopted 17 December 2001), groups of fasted, 8-12 weeks old, Wistar strain rats (3 females) were given a single oral dose of PHMA at doses of 300 and 2000 mg/kg bw and observed for 14 days.A group of three fasted females was treated with the test item at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at dose levels of 300 and 2000 mg/kg bw. Dosing was performed sequentially.
There were no deaths at a dose level of 300 mg/kg bw. All animals of the 2000 mg/kg bw dose group were killed for humane reasons 1 h after dosing, due to occurrence of severe clinical signs of toxicity (body tremors, prostration, ptosis, loss of righting reflex, laboured/noisy respiration). In the 300 mg/kg bw dose groups 2/6 animals showed no signs of systemic toxicity; in 4/6 animals ataxia,lethargy and/or hunched posture was observed.
The surviving animals showed the expected body weight gains. No abnormalities were observed at necropsy in animals of the 300 mg/kg bw dose group. Clear liquid present in the stomach and epithelial sloughing of the gastric mucosa were noted at necropsy of animals treated with 2000 mg/kg bw.
Oral LD50 (rat, female): according to Annex 2c of OECD Guideline 423 an LD50 of 500 mg/kg bw was estimated
Justification for selection of acute toxicity – oral endpoint
OECD guideline study; GLP
Justification for classification or non-classification
Based on the available data, PHMA is classified as Hazard Category 4 for acute oral toxicity according to CLP, EU GHS (Regulation (EC) No 1272/2008) and labelled with H302 (harmful if swallowed) since the oral LD50 in rats is ca. 500 mg/kg bw (category definition: 300 mg/kg bw < ATE </= 2000 mg/kg bw).
According to Directive 67/548 EEC, PHMA is classified as Xn, Harmful, R22 (harmful if swallowed).
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