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EC number: 233-713-2 | CAS number: 10326-41-7
- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolates, methyl, ethyl, propyl, and butyl glycolates, and lactic acid, ammonium, calcium, potassium, sodium, and TEA-lactates, methyl, ethyl, isopropyl, …
- Author:
- Andersen, F.A.
- Year:
- 1 998
- Bibliographic source:
- International Journal of Toxicology 17 (Suppl. 1)
Materials and methods
- Study type:
- study with volunteers
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
Constituent 1
Method
- Route of administration:
- dermal
- Details on study design:
- A RIPT was completed using 99 of 115 initial subjects to determine the primary or cumulative irritation and/or sensitization potential of anhydrous emulsions containing 2.0, 3.0, 4.0, or 5.0% Lactic Acid (Consumer Product Testing Co., 1993c). Approximately 0.2 mL of each test material was applied for 24 h to the upper back (between the scapulae) of each subject using semi-occlusive patches three times/week for a total of 10 applications. Around 14 days after the last application, an open patch challenge application was made to the original site and to a previously untreated site on the volar forearm. The sites were scored 24 and 48 h after application.
Results and discussion
- Results of examinations:
- One subject had a response of mild erythema at the original test site 48 h after application of the formulation containing 2.0% Lactic Acid; another subject had the same response to the 3.0% formulation at the test site after 48 h. A third subject had a response of mild erythema to the 3.0, 4.0, and 5.0% Lactic Acid formulations at the previously untreated site. No responses were recorded for nthe other subjects. The three subjects that had a reaction were rechallenged as previously described for the original challenge. A reaction of nmild erythema was recorded after 24 h, but not 48 h, at the previously untreated site for the subject that had a reaction to the 2.0% formulation ; the response was considered weak and transitory and clinically ninsignificant. No reaction was observed upon rechallenge of the subject that had a reaction to the 3% formulation. Upon rechallenge of the subject that reacted to the 3.0, 4.0, and 5.0% Lactic Acid formulations, a response to the test materials of mild erythema was observed at the previously untreated site after 24 and 48 h; the researchers stated that the response could be due to hypersensitivity and could probably be considered clinically insignificant. The researchers concluded that studies with anhydrous microemulsions containing 2.0, 3.0, 4.0, and 5.0% Lactic Acid do not indicate a significant potential for dermal irritation or sensitization.
Applicant's summary and conclusion
- Conclusions:
- Based on the results presented in the review publication by Andersen, lactic acid in concentrations of up to 5% is not sensitizing to the skin in repeated insult patch tests.
- Executive summary:
Based on the results presented in the review publication by Andersen, lactic acid in concentrations of up to 5% is not sensitizing to the skin in repeated insult patch tests.
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