Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-196-2 | CAS number: 79-33-4
- 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
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to birds: acute oral toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SY-83 is a manufacturers code name for lactic acid solution.
- Dose method:
- gavage
- Analytical monitoring:
- not specified
- Vehicle:
- yes
- Details on preparation and analysis of diet:
- DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes - Test organisms (species):
- Colinus virginianus
- Details on test organisms:
- Apparently healthy, pen-reared, mature bobwhite, phenotypically indistinguishable from wild birds, were brought into the laboratory facility, examined for physical injury and acclimated for at least 14 days.
- Limit test:
- no
- Remarks:
- Single dose test
- Post exposure observation period:
- 14 days
- No. of animals per sex per dose and/or stage:
- 10 (5 m, 5 f)
- Nominal and measured doses / concentrations:
- 292, 486, 810, 1350 and 2250 milligrams of test item per kilogram of body weight.
- Details on test conditions:
- ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): same
- Feeding: ad lib
- Health (any disease or mortality observed): none
- Fasting period before study: 15 h
PEN SIZE AND CONSTRUCTION MATERIALS
The birds were housed indoors during the test period by treatment group in modified Georqia Quail Farm Breeder units (Model No. 0010). Each pen measured approximately 78 X 51 X 23 cm. high and housed five cocks or five hens. External walls,ceilings an dfloors were constructed of galvanized wire grid, while the common walls were constructed of galvanized sheeting.
NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10
NO. OF REPLICATES PER GROUP
- For negative control: 1
- For treated: 1
TEST CONDITIONS (range, mean, SD as applicable)
Average temperature for the study was 77°F ± 4°F (SD), with an average relativ ehumidity of 74%. Th ephotoperiod (maintained by a time clock) was eight hours of light per day throughou tth estudy. The birds received approximately twelve footcandles of illumination. The light source was Chroma 50 fluorescent lights which closely approximate noon-day sunlight (noon-day sun - 4870° Keivin, Chroma 50 - 5000° Keivin). - Details on examinations and observations:
- All birds were observed daily throughout the study, and a record was maintained of all mortalities and/or signs of toxicity and abnormal behavior. The LD50 value of SY-83 to the bobwhite was determined by inspection.
Body weights were recorded individually at initiation, and by group on Days 3, 7, and at termination of the study on Day 14. Feed consumption was measured for Days 0-3, 4-7, and 8-14. Feed consumption was measured accurately but is presented as an estimate due to the unavoidable wastage by the birds. - Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 14 d
- Dose descriptor:
- LC50
- Effect level:
- > 2 250 mg/kg bw
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Mortality and sub-lethal effects:
- There was an apparent dosage related effect on body weight of males at the 1350 mg/kg and 2250 mg/kg dosages for Days 0-3. There appeared to be no effect on feed consumption at any dosage.
- Further details on results:
- In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no-observed-effect dosage was 810 mg/kg.
- Executive summary:
The acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no-observed-effect dosage was 810 mg/kg. Since lactic acid is an essential molecule for life and has an extensive role in metabolism, this may be just a result of an equilibrium shift in metabolic pathways.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- short-term toxicity to birds: dietary toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-2 (Avian Dietary Toxicity Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SY-83
- Test organisms (species):
- Colinus virginianus
- Limit test:
- no
- Total exposure duration (if not single dose):
- 8 d
- No. of animals per sex per dose and/or stage:
- 5
- Nominal and measured doses / concentrations:
- 562, 1000 ,1780, 3160 & 5620 ppm
- Key result
- Duration (if not single dose):
- 8 d
- Dose descriptor:
- LC50
- Effect level:
- > 5 620 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Duration (if not single dose):
- 8 d
- Dose descriptor:
- NOEC
- Effect level:
- >= 5 620 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: external observations of (any) abnormality
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, the LC50 of SY-83 to the bobwhite in this study was greater than 5620 ppm, the highest concentration tested. No apparent treatment related mortalities occurred. The no-observed-effect concentration was 5620 ppm.
- Executive summary:
The LC50 of SY-83 to the bobwhite in this study was greater than 5620 ppm, the highest concentration tested. No apparent treatment related mortalities occurred. The no-observed-effect concentration was 5620 ppm.
- Endpoint:
- short-term toxicity to birds: dietary toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-2 (Avian Dietary Toxicity Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SY-83
- Dose method:
- gavage
- Analytical monitoring:
- no
- Test organisms (species):
- Anas platyrhynchos
- Limit test:
- no
- Total exposure duration (if not single dose):
- 8 d
- No. of animals per sex per dose and/or stage:
- 5
- Nominal and measured doses / concentrations:
- 562, 1000, 1780, 3160 & 5620 ppm
- Key result
- Duration (if not single dose):
- 8 d
- Dose descriptor:
- LC50
- Effect level:
- > 5 620 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Duration (if not single dose):
- 8 d
- Dose descriptor:
- NOEC
- Effect level:
- >= 5 620 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: any external observation
- Validity criteria fulfilled:
- not specified
- Conclusions:
- In conclusion, the dietary LC50 value of SY-83 to the mallard in this study was greater than 5620 ppm, the highest concentration tested. The no-observed-effect concentration was also 5620 ppm.
- Executive summary:
Controls - There were no mortalities in the control group. All birds were normal in appearance and behavior throughout the test period.
SY-83 - There were no signs of toxicity, abnormal behavior or mortality in any test group. All birds were normal in appearance and behavior throughout the test period. When compared to the control, there was no effect on body weight or feed consumption throughout the test period. The dietary LC50 value of SY-83 to the mallard in this study was greater than 5620 ppm, the highest concentration tested. The no-observed-effect concentration was also 5620 ppm.
Referenceopen allclose all
Description of key information
In view of the general lack of systemic toxicity of lactic acid, being an endogenous metabolite both in mammals and birds, a test of reproductive toxicity in birds is not considered to be required. Nevertheless, available studies on L(+)-lactic acid are used for read-across to evaluate the toxicity to birds.
In all three studies the substance seems not be toxic to birds:
LD50 (14d, Colinus virginiaunus) > 2250 mg/kg (highest dosage tested); no mortalities occured; NOEC (male weight) = 810 mg/kg
LC50 (8d, Colinus virginianus and 8d, Anas platyrhynchos) > 5620 ppm (highest dosage tested); no mortalities occurred; NOEC = 5620 ppm
Key value for chemical safety assessment
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.