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EC number: 264-761-2 | CAS number: 64265-45-8
- 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 > 2000 mg a.i./kg bw; OECD TG 423 / Method B.1, rat; oral: gavage; RL1, GLP
Dermal LD50 > 2000 mg a.i./kg bw; OECD TG 402 / Method B.1, rat; RL1, GLP
Inhalation: no relevant route of exposure
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:
- 2007-04-03 to 2007-04-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: Body weight variation did not exceed+/- 20% of the sex mean
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labelled Macrolon cages (MIV type; height 18 cm.) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiaten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 23.1°C
- Humidity (%): 31 - 63%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50.6%
MAXIMUM DOSE VOLUME APPLIED: 3.738 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit dose - Doses:
- 2024 mg a.i./kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15; clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Hunched posture was noted among the animals on Day 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of Amphopropionate C8 in female Wistar rats was established to exceed 2000 mg a.i./kg body weight.
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 423 (2002) and EU Method B1., two groups of three fasted female young adult Wistar ratswere given a single oral dose of Amphopropionate C8 (50.6% a.i.) at the limit dose 2024 mg a.i./kg bw and were observed for14 days.
No mortality occurred. Hunched posture was noted among the animals on Day 1.
Oral LD50 females > 2000 mg a.i./kg bw
Based on these results, Amphopropionate C8 does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- guideline study, GLP, RL1
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-05-09 to 2007-05-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: none
- Housing: Individually housed in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cageenrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiaten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Macrolon cages (MIV type).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 - 23.0°C
- Humidity (%): 39 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 May 2007 To: 23 May 2007 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5x7 cm
- % coverage: 10%
- Type of wrap if used: The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1 D), successively covered with aluminum foil and Caban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only
REMOVAL OF TEST SUBSTANCE
24 hours after application the dressings were removed and the skin cleaned of residual test substance using tap water
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3738 mL/kg; 2024 mg a.i./kg bw
- Concentration (if solution): 50.6%
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2024 mg a.i./kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15; clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Lethargy, flat posture, piloerection (head), chromodacryorrhoea (snout) and/or ptosis was noted among the animals. The animals had recovered from the symptoms between Days 2 and 3. Focal erythema, scars, scales and/or scabs were seen in the treated skin-
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of Amphopropionate C8 in Wistar rats was established to exceed 2000 mg a.i./kg body weight.
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402 (1987) and EU Method B.3 (1992), groups of young adult Wistar rats (5 males and 5 females) were dermally exposed to Amphopropionate C8 (50.6% a.i.) for 24 hours to the limit dose of 2024 mg a.i./kg bw. Animals then were observed for 14 days.
No mortality occurred. Lethargy, flat posture, piloerection (head), chromodacryorrhoea (snout) and/or ptosis was noted among the animals. The animals had recovered from the symptoms between Days 2 and 3. Focal erythema, scars, scales and/or scabs were seen in the treated skin-area of the females during the observation period.
Dermal LD50 Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
Based on these results, Amphopropionate C8 does not have to be classified and has no obligatory labelling requirement for dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- guideline study, GLP, RL1
Additional information
Acute oral toxicity
In an acute oral toxicity study according to OECD Guideline 423 (2002) and EU Method B1., two groups of three fasted female young adult Wistar ratswere given a single oral dose of Amphopropionate C8 (50.6% a.i.) at the limit dose 2024 mg a.i./kg bw and were observed for14 days.
No mortality occurred. Hunched posture was noted among the animals on Day 1.
Oral LD50 females > 2000 mg a.i./kg bw
Acute inhalation toxicity
Given that inhalation is not a relevant route of exposure, testing by the inhalation route is not necessary according to REACH Regulation Annex VIII 8.5.2 Column 2. Inhalation is not a relevant route of exposure to Amphopropionate C8. This applies to both workers and the general population and is due to the physicochemical properties of the substance and the nature of the products where it is used. Vaporisation needs not to be considered due to the substance’s low vapour pressure of <1.47E-03 Pa at 20°C. The generation of aerosols is excluded by technical means or product design. The substance is not used in spray applications. The most likely route of human exposure for workers and consumers is the dermal route. Results of laboratory animal studies show a low acute toxicity after oral and dermal exposure. Therefore the acute intrinsic toxic activity of the substance is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.
Acute dermal toxicity
In an acute dermal toxicity study according to OECD guideline 402 (1987) and EU Method B.3 (1992), groups of young adult Wistar rats (5 males and 5 females) were dermally exposed to Amphopropionate C8 (50.6% a.i.) for 24 hours to the limit dose of 2024 mg a.i./kg bw. Animals then were observed for 14 days.
No mortality occurred. Lethargy, flat posture, piloerection (head), chromodacryorrhoea (snout) and/or ptosis was noted among the animals. The animals had recovered from the symptoms between Days 2 and 3. Focal erythema, scars, scales and/or scabs were seen in the treated skin-area of the females during the observation period.
Dermal LD50 Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
There are no data gaps for the endpoint acute toxicity. No human data are available. However, there is no reason to believe that these results from rat would not be applicable to humans.
Justification for classification or non-classification
Based on the available data, Amphopropionate C8 does not have to be classified and has no obligatory labelling requirement for acute oral, dermal or inhalation toxicity according to Regulation (EC) No 1272/2008).
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