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EC number: 252-036-3 | CAS number: 34451-19-9
- 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:
- 1996-08-26 to 1996-10-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in July 1992
- Deviations:
- yes
- Remarks:
- The relative humidity of the animal room was higher than the upper limit mentioned in the guidelines
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butyl (S)-2-hydroxypropionate
- EC Number:
- 252-036-3
- EC Name:
- Butyl (S)-2-hydroxypropionate
- Cas Number:
- 34451-19-9
- Molecular formula:
- C7H14O3
- IUPAC Name:
- butyl 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- - Name: PURASOLV BL (n-butyl lactate)
- Chemical name: butyl-S-(-)-2-hydroxy propionate
- Package: Plastic bottle
- Batch No: BU-6001K
- CAS. Reg. No: 138-22-7 (although this is the CAS number for butyl lactate of unspecified stereochemistry, the substance is clearly identified as the S-enatiomer)
- Labelling: Butyl lactate PURASOLV BL
- General appearance: Clear, colourless liquid
- Storage conditions: Ambient temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Young adults
- Weight at study initiation: 3350-3910 g
- Sex: Male
- Housing: Individually in stainless steel cages with perforated floor
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 54 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 60-87.5 % (upper limit higher than 70%, because of wet cleaning of the animal room and/or meteorological circumstances; the 87.5% peak occurred for some hours at most)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: removal of hair with electric clippers so as to avoid abrasions
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 × 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with a moistened tissue
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize et al. (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 5
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The irritation scoring is presented in Table 1 below, section 'any other information on results incl. tables'. At 1 hour after treatment, very slight erythema was observed in the three rabbits. At 24 an 48 h post- treatment, well-defined erythema and slight oedema were observed in the three rabbits. One rabbit showed very slight incrustation and all three rabbits slight scaliness at 48 hours after treatment. At 72 hours after treatment, well-defined erythema and very slight or slight oedema were observed in the three rabbits. In addition, one rabbit showed very slight incrustation and all three rabbits slight scaliness. At 14 days after treatment all skin effects had cleared in the skin of all rabbits.
Any other information on results incl. tables
Table 1: Skin irritation scores for n-butyllactate after 4 -h dermal application in rabbits.
Rabbit No |
1 h A B |
24 h A B |
48 h A B |
72 h A B |
7 d A B |
8 |
1-0 |
2-2 |
42-2 |
42,3-2 |
4-0 |
10 |
1-0 |
2-2 |
2-2 |
2-1 |
0-0 |
12 |
1-0 |
2-2 |
2-2 |
23-1 |
0-0 |
Erytherma1 |
1.0 |
2.0 |
3.0 |
3.0 |
n.r. |
Oedema1 |
0.0 |
2.0 |
2.0 |
1.5 |
n.r. |
The average score is calculated for the two animals showing the strongest skin response
A: erythrema
B: oedema
1 The average erythema and oedema score is calculated for the two animals showing the strongest skin response
2 very slight incrustation in combination with well-defined erythema (erythema score = 4)
3 slight scaliness
4 very
slight incrustation and slight scaliness (erythema score = 4), which had
cleared completely at 14 days
after treatment
n.r. = not relevant; only scores 24-72 hours are used for classification
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- n-Butyl-S-lactate is moderately irritating to the skin of rabbits when applied for 4 h under semi-occlusive conditions.
- Executive summary:
A sample of n-Butyl-S-lactate was tested for acute skin irritating/corrosive properties in an experiment with three albino rabbits. The dermal exposure period was 4 hours under semi-occlusive conditions. The test substance caused well-defined erythema, very slight incrustation, slight scaliness and slight oedema in the rabbits. The study design was in accordance with OECD guideline 404 (adopted in July 1992). At 14 days after treatment, the skin effects had cleared completely. On the basis of the results obtained it was concluded that, under the conditions of this study, n-Butyl-S-lactate is moderately irritating to the skin of rabbits after a 4-hour dermal contact period. According to the EC-standards n-butyl-S-lactate is irritating, but not corrosive to (human) skin and it shall be classified as irritant Category 2 (CLP, Regulation EC No 1272/2008).
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