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EC number: 206-058-5 | CAS number: 298-12-4
- 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:
- From 06 Jan. 2004 to 1 Feb. 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data generated according to international accepted valid testing method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422 Guideline for testing of chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Huntingdon Life Sciences, Wooley Road, Alconbury, Huntingdon, Cambridgeshire, PE284HS, England
- Limit test:
- no
Test material
- Reference substance name:
- Glyoxylic acid
- EC Number:
- 206-058-5
- EC Name:
- Glyoxylic acid
- Cas Number:
- 298-12-4
- Molecular formula:
- C2H2O3
- IUPAC Name:
- 2-oxoacetic acid
- Details on test material:
- The test substance was Glyoxylic acid 50 (a 50% w/w solution of glyoxylic acid in water) which was incorporated into the diet of CD rats.
Storage conditions: at ambient temperature or in a refrigerator, unless otherwise directed by the Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- Species: Rat
Strain: Crl:CD (SD) IGS BR
Age ordered: 7 weeks of age males and females not siblings
Weight range ordered: To be within an 15 g range for each sex/batch
Supplier: Charles River (UK) Limited
Acclimatisation:
Duration: At least 5 days before commencement of treatment.
Animal - housing, diet and water supply:
Rodent facility: Full barrier - to minimise entry of external biological and chemical agents.
Air supply: Filtered, not recirculated.
Temperature: Maintened within the range of 19-23°C.
Relative humidity: Maintened within the range of 40-70%
Lighting: 12 hours light: 12 hours dark.
Animal accomodation:
Animal per cage: Males and females housed in mating pairs during mating, males then returned to group housing, females then remain singly housed.
Cage material: Polypropylene or stainless steel.
Diet name: SDS VFR 1 Certified
Diet type: Powdered diet.
These diets contain no added antibiotic or other chemotherapeutic or prophylactic agent.
Water supply: Potable water from the public supply.
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Continuously from 14 days before pairing, during 14-day pairing period, gestation, littering and lactation period until day 4.
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- All 10 males in each group (toxicity and reproductive subgroups) were paired with the 10 reproductive subgroup females after all animals had received 2 weeks of treatment.
Pairing was on a one-to-one basis within treatment groups; up to 2 week was allowed although all animals mated and were separated within 1 week.
From day 20 after mating reproductive subgroup animals were checked 3 times daily for evidence of parturition.
The female were permitted to deliver their young naturally and rear their own offspring until Day 4 of lactation.
Numbers of live and dead offspring were recorded during the parturition process.
All offspring were examined at approximately 24 hours after birth (Day 1) and the number of offspring born (live and dead) was recorded.
Litters were observed daily for evidence of abnormal appearance or behaviour. Daily records were maintained for mortality and consequent changes in litter size.
Reproductive subgroup males were killed during Week 6 of treatment.
Reproductive subgroup females and their offspring were killed on Day 4 of lactation/age (during Weeks 6 or 7 of treatment for the females). - Frequency of treatment:
- Daily in the diet
- Duration of test:
- Approximately 8 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2000, 6000 and 18000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- Four groups of 5 males and 10 females per group
- Control animals:
- yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 18 000 ppm
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 18 000 ppm
- Based on:
- test mat.
- Basis for effect level:
- other: other
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 18 000 ppm (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: screening observation
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Treatment
at all dietary concentrations was well tolerated and there were no
mortalities.
Bodyweight gain and food intake of reproductive subgroup females during
gestation and early lactation was unaffected by treatment.
Achieved dosages for females at the start of gestation (Days 0-7) were
97, 296 and 910 mg/kg/day for females in the 2000, 6000 and 18000 ppm
groups.
Achieved dosages during Days 1-4 of lactation were about 49-56 % higher
(126, 383 and 1257 mg/kg/day respectively) than those at the end of
gestation, reflecting increased physiological demand on the dams by the
litters.
Achieved dosages largely reflected the three-fold difference in dietary
concentrations of Glyoxylic acid 50.
There was no effect of treatment on the sensory reactivity, grip
strength or motor activity of the animals monitored during Week 5.
Mating performance and fertility were unaffected by treatment.
Parental treatment had no effect on the survival, growth or development
of the offspring or absolute or bodyweight relative organ weights.
There were no microscopic pathology changes in the tissues examined that
were considered to be related to treatment.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, it was concluded that the NOAEL for reproductive/developmental toxicity within the scope of this screening test was 18000 ppm.
The study was considered to have met the objectives of the OECD Guideline 422.
The reproduction/developmental toxicity screening test found no evidence of impaired performance at these dietary concentrations.
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