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EC number: 212-762-3 | CAS number: 867-56-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study was conducted according to the AFNOR (Association Française de Normalisation) guidelines (as valid in 1982, the year in which this study was published). Although the used protocol is similar to the current OECD protocol OECD TG 405, it differed in some respects. For instance, the scoring of the eye irritation test was done on a different (but related) scale than the current OECD TG 405 protocol and the applied scoring included a wider range of categories of severity of eye irritation (6 instead of 3 as nowadays applied in OECD TG 405; EC1272/2008). In addition, in this published study, no individual scores for the animals are given, but values based on averages of all animals.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the ocular-irritation potential of 56 compounds
- Author:
- Guillot J.P. et al.
- Year:
- 1 982
- Bibliographic source:
- Food Chem. Toxic. 20, 573-582
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Version of 1979 (deviates from current)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: AFNOR
- Version / remarks:
- Association Français de Normalisation (1982)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Official method approved by the French authorities for the testing of cosmetics and toiletries (Journal Officiel de la République Français, 1971 & 1973)
- Deviations:
- no
- Principles of method if other than guideline:
- Application of 0.1 mL of a 60 % aqueous solution of Sodium lactate into the lower conjunctival sac of one eye per rabbit (the other eye serving as control) to in total 6 New Zealand male albino rabbits and (with no rinsing of the eyes) subsequent observation of the eyes at 1, 24, 48, 72, 96 and 168 hours post substance application. Scoring was done on the AFNOR scale for interpretation of ocular irritation evaluations. The scores represent a total summed score (maximum 110) of the conjunctiva (maximum 20) + iris (maximum 10) + cornea (maximum 80) scores. In addition, reversibility is taking into account in this scoring method (completeness of recovery at 96 hours).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium lactate
- EC Number:
- 200-772-0
- EC Name:
- Sodium lactate
- Cas Number:
- 72-17-3
- Molecular formula:
- C3H5NaO3
- IUPAC Name:
- sodium 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Physical state: colourless liquid
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: substance was applied undiluted
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Roucher SA, Couhé
- Age at study initiation: Not specified
- Weight at study initiation: 2.5 kg
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark/rs light): Not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of a 60 % aqueous solution - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: A scoring system based on the AFNOR recommendations was used with modifications where appropriate. At each observation time, lesions of the conjunctiva, iris and cornea were scored separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual irritation index (IOI) for each animal. Calculation of the mean (and the standard deviation) of the IOI values obtained at any one time gave the mean ocular irritation index (MOI). The greatest MOI obtained over the range of observation times was identified as the acute ocular irritation index (AOI). See Table 1 in box “Any other information on materials & methods incl. tables”.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The observed maximum acute (at 1 or 24 hours) irritation index for sodium lactate was 12 (out of a maximum of 110) . This score would imply a classification "slightly irritant" when using the 1982 AFNOR criteria and categories., ie sodium lactate would end up in category 2 of 6 ranging from non irritant (Cat. 1) to extremely irritant (Cat. 6). After 48 hours, the mean irritation index (i.e. mean of 1, 24 and 48 hours) was 2.5, implying extensive recovery after 48 hours. Taking into account the more elaborate categorization (next to non irritant substances and additional 5 categories of eye irritant substances in the 1982 AFNOR versus only 2 categories on eye irritation severity according to CLP Regulation 1272/2008) and the rapid reversibility of the observed eye effects of Sodium lactate, the substance would not be classified as eye irritant applying CLP classifcation criteria.
- Other effects:
- None of the animals died or showed clinical signs during the course of testing.
Any other information on results incl. tables
Table 2: Ocular irritation indices determined in the rabbit in accordance with the principles of the proposed AFNOR protocol
Test material |
Appearance |
Approx. pH |
Rinsing procedure |
AOI |
MOI |
IOI |
Classification AFNOR |
Sodium lactate (purified, 60 % aqueous solution) |
Colourless liquid |
8.0 |
None |
12.00 |
2.5 [2] |
- |
SII |
AOI: Acute ocular irritation index, which was the 1-hr MOI in the case of the irritant and very irritant substances and was the 24-hr MOI for the severely and extremely irritant substances
MOI: Mean ocular irritation index after the number of days indicated in square brackets.
IOI: Individual ocular irritation index on day 7 in the number of rabbits indicated in brackets.
SI: Slightly irritant
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- In a primary eye irritation study conducted according to AFNOR, Sodium lactate can be considered as not irritating to the eye by appling CLP criteria.
- Executive summary:
In an eye irritation study conducted according to AFNOR, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of six New Zealand White rabbits. Animals were observed for 7 days. At each observation time, lesions of the conjunctive, iris and cornea were scored separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual ocular irritation index (IOI) for each animal. Based on the results, the test item can be considered as not irritating to the eye by applying CLP criteria.
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