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EC number: 266-113-4 | CAS number: 66071-94-1 Substance obtained by the partial removal of water from the liquid resulting from steeping corn in a water and sulphur dioxide solution which is allowed to ferment by the action of naturally occurring lactic acid-producing microorganisms.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study without detailed documentation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Concurrent ingestion of lactate and Aluminium can result in developmental toxicity in mice
- Author:
- Colomina MT, Gómez M, Domingo JL, Llobet JM & Corbella J
- Year:
- 1 992
- Bibliographic source:
- Res.Commun. Chem. Pathol. Pharmacol. 77: 95-106 (1992)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Mice were exposed by gavage daily on gestation days 6-15. Cesarean sections were performed on gestation day 18.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Lactic acid
- EC Number:
- 200-018-0
- EC Name:
- Lactic acid
- Cas Number:
- 50-21-5
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 2-hydroxypropanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Lactic acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna Ibérica, Barcelona, Spain
- Age at study initiation: Not reported
- Weight at study initiation: 28 to 32 g
- Fasting period before study: Not reported
- Housing: Plug-positive females were housed in solid-bottom polycarbonated cages with stainless steel wire lids; no futher details provided.
- Diet (e.g. ad libitum): Feed (Panlab rodent chow, Barcelona), ad libitum
- Water (e.g. ad libitum): Water (source not reported), ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 to 60
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Not reported
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not reported
- Details on mating procedure:
- - Impregnation procedure: co-housed
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: overnight
- Proof of pregnancy: vaginal plug designated as day 0 of pregnancy - Duration of treatment / exposure:
- Gestational days 6-15
- Frequency of treatment:
- Daily
- Duration of test:
- 10 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
570 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12 dams
- Control animals:
- other: a control group received distilled water during the same period (13 dams).
- Details on study design:
- Not reported
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: Daily for pretreatment, treatment, and post-treatment periods
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 18
- Organs examined: Uteri - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included: Gravid uterus weight, number of total implantations, number of live and dead fetuses, and number of resorptions. - Fetal examinations:
- - External examinations: Yes: all per litter
- All live fetuses were removed from the uterus, weighed, sexed, and examined for external abnormalities. After the external examination was completed, approximately one-third of the fetuses from each group were fixed in Bouin’s solution and examined for visceral anomalies. The remaining fetuses were fixed with Alizarin red solution and examined for skeletal abnormalities. - Statistics:
- Test groups were compared to the control group at a level of significance of p<0.05. Results of the continous variables (e.g., maternal body weight, food consumption, fetal weight, etc) were analyzed using a one-way analysis of variance (ANOVA) with significant F values further analyzed using Duncan's multiple range test. Nonparametic data were statistically evaluated using the Kruskal-Wallis test when appropriate. Incidence data were compared using chi square contingency tables.
- Indices:
- Not reported
- Historical control data:
- Not reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
-No effects on maternal body weight were observed. Food consumption was significantly reduced during the treatment (Gestation days 6 to 9 and 6 to 12) and post-treatment periods (Gestation days 15 to 18). Gravid uterine weight, absolute liver weight, and absolute and relative kidney weight were not affected by the treatment. A significant decrease in relative liver weight in the lactic acid group compared to the control group was noted.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 570 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Evaluation of gestational parameters for the mice did not show significant treatment-related effects on the number of total implantations per litter, viable or non-viable implants per litter, percentage postimplantation loss, or sex ratio. Incidence of delayed ossification of parietals was noted. However, anatomical malformations or variations were not noted to occur with a higher incidence than controls in lactic acid group.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 570 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- 570 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Lactic acid was neither maternotoxic, embryofetotoxic, nor teratogenic when given orally to mice at 570 mg/kg bw/day on gestation days 6-15.
Applicant's summary and conclusion
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