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EC number: 211-694-1 | CAS number: 687-47-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-06-19 to 1995-07-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17th July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl (S)-2-hydroxypropionate
- EC Number:
- 211-694-1
- EC Name:
- Ethyl (S)-2-hydroxypropionate
- Cas Number:
- 687-47-8
- Molecular formula:
- C5H10O3
- IUPAC Name:
- ethyl 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material used in the report: ethyllactate
- CAS No.: 687-47-8
- Trade name: Purasolv EL
- Batch No.: 950122
- Appearance: clear, colourless liquid
- Purity: 98%
- Storage: ambient
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF bred New Zealand White albino rabbits were obtained from the Broekmans Institue, Someren, the Netherlands
- Age at study initiation: males, young adult
- Weight at study initiation: 2130-2220 g
- Housing: individually in stainless steel cages, fitted with perforated floor
- Diet (e.g. ad libitum): standard laboratory rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 6/7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 52.5-75
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- An amount of 0.5 mL of the test substance was distributed over a patch measuring 2.5 x 2.5 cm.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- Three or four days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. One day prior to application of the test material, the skin site was inspected for hair growth and the clipping was repeated. Just prior to application, a skin site suitable for application was selected on the clipped back and flanks of the animal. An amount of 0.5 mL of the test substance was distributed over a patch measuring 2.5 x 2.5 cm. The patch loaded with the test substance was fixed tot the selected application site by means of adhesive tape. Subsequently, the entire trunk of the rabbit was wrapped with self-adhesive-gauze to maintain the patch in position and to retard evaporation of volatile substances. The gauze was additionally fastened with two stripes of tape. After a 4-hour exposure period, the test substance and patch were removed, and the test site was cleaned with a moistened tissue. Circa 1 hour later, the resulting skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390). Further skin readings were made at approximately 24, 48 and 72 hours, and at 7 and 14 days after treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See Table 1 in box "Any other information on results incl. tables".
- Other effects:
- At 7 days after treatment, slight scaliness was observed in the two rabbits that showed skin irritation during the first days on the edges of the application area (<1 mm) only. At 14 days after treatment, the scaliness had cleared.
Any other information on results incl. tables
Table 1 - Skin irritation scores of ethyl lactate, after a single 4-hour dermal exposure
Animal no. |
Hours or days after removal of the test material: |
||||
1 hr |
24 hr |
48 hr |
72 hr |
7 d |
|
A-B |
A-B |
A-B |
A-B |
A-B |
|
12 |
0-0 (1-1) |
0-0 (2-2) |
0-0 (2-2) |
0-0 (2-1) |
0-0 |
8 |
0-0 (1-1) |
0-0 (2-2) |
0-0 (2-2) |
0-0 (2-1) |
0-0 |
14 |
0-0 (1-1) |
0-0 (1-1) |
0-0 |
0-0 |
|
Erythema (A): |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Oedema (B): |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
() Skin effects were located on a very small skin area on the edge of the application area (width less than 1 mm), most probably caused by pressure of the bandage on the test patch underneath. Therefore, the toxicological significance of these skin effects is considered dubious.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the given conditions, the test item is not irritating to the skin of rabbits.
- Executive summary:
In a primary dermal irritation study (according to OECD Guideline 404), young adult male SPF bred New Zealand White albino rabbits (n= 3; weight 2130 - 2220 g) were dermally exposed to 0.5 mL of ethyl (S)-lactate (purity: 98%) to an area of 2.5 x 2.5 cm under occlusive conditions for 4 hours. Animals were then observed for 14 days and irritation was scored by the method of Draize et al. Only mild skin effects were observed on a very small skin area on the edge of the application area, most probably by pressure of the bandage on the test patch underneath. Since normally these kind of exposure conditions will not occur in humans, the toxicological significance of these skin effects was considered dubious. Furthermore, the mean erythema and oedema scores were 0. Based on these results, Ethyl (S)-lactate can be considered as non-irritant to the skin of rabbits. Therefore, classification for skin irritation according to CLP Regulation 1272/2008 is not warranted.
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