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EC number: 470-870-8 | CAS number: 690271-93-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02-06-2009 to 03-07-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Terracess P
- IUPAC Name:
- Terracess P
- Details on test material:
- Batch: 0G99
White powder
Expiry date: 21 August 2001
Test substance storage: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany.
- Age at study initiation: approximately 14 weeks.
- Weight at study initiation: 199-261 grams (day 0 post-coitum)
- Fasting period before study: not applicable
- Housing:
Pre-mating During acclimatization, females were housed in groups of 5 animals/cage in
Macrolon cages (MIV type, height 18 cm). During the weekend, mating procedures were suspended and the animals were housed in groups of maximum 5 animals/sex/cage in Macrolon cages (MIV type, height 18 cm).
Mating Females were caged together with males on a one-to-one-basis in Macrolon
cages (MIII type, height 18 cm).
Post-coitum Females were individually housed in Macrolon cages (MIII type, height 18 cm).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days prior to the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-21.3
- Humidity (%): 34-79
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 02 June 2009 (start pairing) To: 23 June 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations (w/w) were prepared daily within 6 hours prior to dosing and were homogenized to a visually acceptable level. No adjustment was made for specific gravity of the test substance, vehicle, and/or formulation.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Based on trial formulations
- Concentration in vehicle: 20, 60, 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis (for accuracy and homogeneity) was done on one day during the treatment period (09 June 2009) according to a validated method (NOTOX Project 490988). The analytical method for the quantitative analysis of the test substance in formulation is based on total Titanium analysis after acidic digestion. During this digestion, the test substance is split into individual ions. The test substance cannot be analysed in its original form. Stability of the test substance in formulations could therefore not be tested.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Verification of same strain and source of both sexes: [yes ]
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
-After successful mating each pregnant female was caged: individually
-Any other deviations from standard protocol: no - Duration of treatment / exposure:
- From day 6 to day 19 post-coitum, inclusive.
- Frequency of treatment:
- Once daily for 7 days per week, approximately the same time each day with a maximum of 6 hours difference between the earliest and latest dose.
- Duration of test:
- 02 June 2009 (start pairing) to 03 July 2009 (end of in-life phase).
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 24 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels were selected based on results of the dose range finding study (NOTOX Project 490450). Four groups of 6 females were exposed to 100, 300 and 1000 mg/kg/day for Days 6 to 19 post-coitum inclusive by oral gavage. There were no signs of toxicity.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least twice daily
- Cage side observations: Mortality/Viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At least once daily from Day 0 post-coitum onwards
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 3 and 6-20 (daily) post-coitum.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, determined on Days 0-3, 3-6, 6-9, 9-12, 12-15, 15-17 and 17-20 post-coitum.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day: Day 20 post-coitum
- Organs examined: External, thoracic and abdominal organs - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter - Statistics:
- The following statistical methods were used to analyse the data:
- If the variables could be assumed to follow a normal distribution, the Dunnett-test (Dunnett,
1955) (many-to-one t-test) based on a pooled variance estimate was applied for the
comparison of the treated groups and the control groups for each sex.
- The Steel-test (Miller, 1981) (many-to-one rank test) was applied if the data could not be
assumed to follow a normal distribution.
- The Fisher Exact-test (Fisher 1950) was applied to frequency data.
Mean litter proportions (percent per litter) of total fetal malformations and developmental
variations (external, visceral, skeletal and combined), and each particular external, visceral and
skeletal malformation or variation was subjected to the Kruskal-Wallis nonparametric ANOVA
test (Kruskal and Wallis 1952) to determine intergroup differences. If the ANOVA revealed
statistically significant (p<0.05) intergroup variance, Dunn’s test (Dunn 1964) was used to
compare the compound-treated groups to the control group.
All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of
significance. Group means were calculated for continuous data and medians were calculated for
discrete data (scores) in the summary tables. Test statistics were calculated on the basis of
exact values for means and pooled variances. - Indices:
- For each dose group reproduction parameters were expressed in two ways:
-As a mean (with standard deviation) of the number observed for each litter
-As a mean litter proportion calculated on a total group basis
For each litter the following calculations were performed:
Pre-implantation loss = (Number of corpora lutea - number of implantation sites) / Number of corpora lutea x 100
Post -implantation loss = (Number of implantation sites - number of live fetuses) / Number of implantation sites x 100
The fetal developmental findings were summarized by: 1) presenting the incidence of a given
finding both as the number of fetuses and the number of litters available for examination in the
group; and 2) considering the litter as the basic unit for comparison, calculating the number of
affected fetuses as a mean litter proportion on a total group basis.
Where:
Viable Fetuses Affected/Litter (%) = ( No. Viable Fetuses Affected/Litter) / No. Viable Fetuses/Litter x 100 - Historical control data:
- NOTOX Historical control data were used for external, visceral and skeletal malformations.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Animal 42, Group 2 (100 mg/kg) had hunched posture, ptosis, piloerection, hypothermia and lethargy on Day 19 post coitum and was killed in extremis (see 7.2.1. Mortality above). Due to the isolated nature of these findings, seen only in one animal on a single day of the treatment period, they were likely due to chance and not indicative of treatment-related toxicity.
Incidental findings included alopecia of various body parts. This is not uncommonly seen in animals of this age and strain, and does not indicate treatment-related toxicity. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Animal 42, Group 2 (100 mg/kg) was killed in extremis on Day 19 post coitum. Dark red discoloration and hardening of the uterus and cervical torsion were noted at the macroscopic examination; as this was an isolated finding, and in the absence of any dose-related relationship, these findings were not indicative of treatment-related toxicity.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no effects on body weights (before or after correction for gravid uterine weights) or % of body weight gain with treatment of TERRACESS P up to 1000 mg/kg.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Absolute and relative food consumption were unaffected with treatment of TERRACESS P up to 1000 mg/kg.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no test substance related effects on macroscopic findings at any dose level. Incidental findings included alopecia of various body parts. A single female, animal 42 (100
mg/kg) was killed in extremis on Day 19 of post coitum; see the Mortality section for the macroscopic findings noted for this animal. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- effects observed, non-treatment-related
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There were no toxic effects observed.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- mortality
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- maternal abnormalities
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Mean fetal body weights were 3.6, 3.5, 3.5 and 3.6 grams for Groups 1, 2, 3 and 4, respectively.
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- Male:female sex ratios were comparable between controls and all treatment groups.
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- Mean litter sizes were 11.0, 11.5, 11.9 and 10.5 fetuses for Groups 1, 2, 3 and 4, respectively.
- Changes in postnatal survival:
- not specified
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects on fetal external morphology. Fetus no. A094-01 in the 1000 mg/kg group had a cyst-like growth from a cleft in the anterior palate into the buccal cavity. At visceral cephalic examination this fetus also showed anophthalmia (the right eye was absent) and misshapen brain. The isolated nature of these findings did not indicate any association with test substance treatment. No external developmental malformations or variations were observed in any other fetuses in this study. One fetus in the 100 mg/kg group (no. A045-02) and one fetus at 1000 mg/kg (no. A083-04) had their placenta grown together with an adjacent placenta. This finding was considered a pathological alteration and not a developmental alteration, and therefore was not classified as
either a malformation or a developmental variation and was not included in the summary tables, but was included in the individual tables. - Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects on fetal skeletal morphology. Control fetus A024-02 had fused skull bones (the jugal was fused to the maxilla, unilateral). No other skeletal malformations were noted in this study. The mean litter proportion of bent ribs was 10.0%, 4.0%, 1.0% and 6.1% in the control, 100, 300 and 1000 mg/kg groups, respectively. At 300 mg/kg, the mean litter proportion of bent ribs was significantly lower than in the control group and lower than the minimum historical control value (historical control data range: 6.7% - 15.2%). However, a decrease in the number of fetuses
with bent ribs is not an adverse effect and the group distribution for this finding does not suggest a relation to test substance treatment. Therefore, the decreased number of fetuses with bent ribs at 300 mg/kg was considered to have arisen by chance.
Other skeletal developmental variations observed in the test substance groups were 14th rudimentary ribs, ossified cervical centrum no. 1, slightly to moderately malaligned sternebra(e), reduced ossification of the skull, 7th cervical rib(s), unossified metacarpals and metatarsals, unossified sternebra(e), 14th full ribs, 27 presacral vertebrae, generalized reduced ossification of the entire skeleton, unossified hyoid, unco-ossified and unossified vertebral centra. All these variations occurred at similar frequencies in the control group, occurred infrequently and/or in a manner that was not dose-related. - Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test substance-related effects on fetal visceral morphology.
Fetus no. A078-01 in the 1000 mg/kg group had external hydrocephaly (increase in space between the brain and the dura mater) and fetus A034-02 at 100 mg/kg had microphthalmia (left eye). Because each finding occurred in single fetuses and was seen in NOTOX historical controls (hydrocephaly) or occurred in the lowest dose group (microphthalmia), they were not considered related to the test substance.
No other visceral malformations were observed in this study. Visceral developmental variations observed in the test substance groups were accessory liver lobules, hemorrhagic adrenals, pale spleen and accessory spleen. All these variations occurred at similar frequencies in the control group and/or occurred infrequently.
One control fetus (no. A007-16) had a red area on the heart. This finding was considered a pathological alteration and not developmental alteration, and therefore was not classified as
either a malformation or a developmental variation and was not included in the summary tables, but was included in the individual tables. - Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no toxic effects observed.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Localisation:
- external: cranium
- external: ear
- external: eye
- external: face
- external: limb
- external: paw
- external: tail
- external: trunk
- external: anogenital distance
- external: anus
- external: genital tubercle
- external: large intestine
- external: thorax
- external: umbilicus
- external: pelvic region
- skeletal: skull
- skeletal: skull, fontanelles
- skeletal: skull sutures
- skeletal: clavicle
- skeletal: scapule
- skeletal: forelimb
- skeletal: sternum
- skeletal: rib
- skeletal: supernumerary rib
- skeletal: vertebra
- skeletal: pelvic girdle
- skeletal: hindlimb
- visceral/soft tissue: integumentary
- visceral/soft tissue: gastrointestinal tract
- visceral/soft tissue: hepatobiliary
- visceral/soft tissue: urinary
- visceral/soft tissue: cardiovascular
- visceral/soft tissue: heamatopoietic
- visceral/soft tissue: immune system
- visceral/soft tissue: musculoskeletal system
- visceral/soft tissue: nervous system
- visceral/soft tissue: central nervous system
- visceral/soft tissue: peripheral nervous system
- visceral/soft tissue: somatic nervous system
- visceral/soft tissue: autonomic nervous system
- visceral/soft tissue: endocrine system
- visceral/soft tissue: respiratory system
- visceral/soft tissue: male reproductive system
- visceral/soft tissue: female reproductive system
- visceral/soft tissue: eye
- visceral/soft tissue: ear
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Accuracy and homogeneity of formulations were demonstrated by analyses.
Maternal effects noted
Mortality:
Animal 42, Group 2 (100 mg/kg) was killed in extremis on Day 19 post coitum. Dark red discoloration and hardening of the uterus and cervical torsion were noted at the macroscopic examination; as this was an isolated finding, and in the absence of any dose-related relationship, these findings were not indicative of treatment-related toxicity.
Clinical signs:
Animal 42, Group 2 (100 mg/kg) had hunched posture, ptosis, piloerection, hypothermia and lethargy on Day 19 post coitum and was killed in extremis (see 7.2.1. Mortality above). Due to the isolated nature of these findings, seen only in one animal on a single day of the treatment period, they were likely due to chance and not indicative of treatment-related toxicity.
Incidental findings included alopecia of various body parts. This is not uncommonly seen in animals of this age and strain, and does not indicate treatment-related toxicity.
Fetal effects noted, external malformations and variations:
There were no test substance-related effects on fetal external morphology.
One fetus in the 1000 mg/kg group had a cyst-like growth from a cleft in the anterior palate into the buccal cavity. At visceral cephalic examination this fetus also showed anophthalmia (the right eye was absent) and misshapen brain. The isolated nature of these findings did not indicate any association with test substance treatment.
No external developmental malformations or variations were observed in any other fetuses in this study.
One fetus in the 100 mg/kg group and one fetus at 1000 mg/kg had their placenta grown together with an adjacent placenta. This finding was considered a pathological alteration and not a developmental alteration, and therefore was not classified as either a malformation or a developmental variation and was not included in the summary tables, but was included in the individual tables.
Visceral malformations and variations:
There were no test substance-related effects on fetal visceral morphology.
One fetus in the 1000 mg/kg group had external hydrocephaly (increase in space between the brain and the dura mater) and one fetus at 100 mg/kg had microphthalmia (left eye). Because each finding occurred in single fetuses and was seen in historical controls (hydrocephaly) or occurred in the lowest dose group (microphthalmia), they were not considered related to the test substance.
No other visceral malformations were observed in this study.
Visceral developmental variations observed in the test substance groups were accessory liver lobules, hemorrhagic adrenals, pale spleen and accessory spleen. All these variations occurred at similar frequencies in the control group and/or occurred infrequently.
One control fetus had a red area on the heart. This finding was considered a pathological alteration and not developmental alteration, and therefore was not classified as either a malformation or a developmental variation.
Skeletal malformations and variations:
There were no test substance-related effects on fetal skeletal morphology.
One control fetus had fused skull bones (the jugal was fused to the maxilla, unilateral). No other skeletal malformations were noted in this study.
The mean litter proportion of bent ribs was 10.0%, 4.0%, 1.0% and 6.1% in the control, 100, 300 and 1000 mg/kg groups, respectively. At 300 mg/kg, the mean litter proportion of bent ribs was significantly lower than in the control group and lower than the minimum historical control value (historical control data range: 6.7% - 15.2%). However, a decrease in the number of fetuses with bent ribs is not an adverse effect and the group distribution for this finding does not suggest a relation to test substance treatment. Therefore, the decreased number of fetuses with bent ribs at 300 mg/kg was considered to have arisen by chance.
Other skeletal developmental variations observed in the test substance groups were 14thrudimentary ribs, ossified cervical centrum no. 1, slightly to moderately malaligned sternebra(e), reduced ossification of the skull, 7thcervical rib(s), unossified metacarpals and metatarsals, unossified sternebra(e), 14thfull ribs, 27 presacral vertebrae, generalized reduced ossification of the entire skeleton, unossified hyoid, unco-ossified and unossified vertebral centra. All these variations occurred at similar frequencies in the control group, occurred infrequently and/or in a manner that was not dose-related.
Applicant's summary and conclusion
- Conclusions:
- Mated female Wistar Han rats were assigned to four dose groups, each containing twenty-four animals. The test item was administered once daily by gavage from Day 6 to 19 post-coitum at doses of 100, 300 and 1000 mg/kg/day (Groups 2, 3 and 4 respectively). The rats of the control group received the vehicle, 1% aqueous carboxymethyl cellulose, alone. Accuracy and homogeneity of formulations were demonstrated by analyses.
Maternal findings
No maternal toxicity was observed in the 100, 300 and 1000 mg/kg/day groups.
Developmental findings
No developmental toxicity was observed in the 100, 300 and 1000 mg/kg/day groups.
In conclusion, based on the results in this prenatal developmental toxicity study, the maternal and developmental No Observed Adverse Effect Level (NOAEL) for TERRACESS P was established as being at least 1000 mg/kg body weight/day.
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