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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-03-02 to 1995-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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: n-butyl lactate
- Chemical name: butyl-(S)-2-hydroxypropionate
- CAS: 34451-19-9 (S-isomer), 138-22-7 (general)
- Labeling: Butyl lactate
- Package: White, plastic bottle
- Purity: 99.06 %
- General appearance: Clear, colourless liquid
- Storage conditions: Ambient
Test animals / tissue source
- Species:
- other: chicken eyes
- Details on test animals or tissues and environmental conditions:
- Approximately 7 weeks old, male or female chickens (ROSS, spring chickens), body weight range approximately 2.5–3.0 kg, were used as eye-donors. Heads of these animals were obtained from poultry slaughterhouse v.d. Bor, Amersfoortseweg 118, Nijkerkerveen, the Netherlands. Within 2 hours after kill, eyes were carefully dissected and placed in a supervision apparatus. The enucleated eyes were placed in a stainless steel clamp with the cornea positioned vertically and transferred to a chamber of the superfusion apparatus. The corneal integrity was assessed in all eyes. Eyes with a corneal thickness deviating more than 10 % of the average corneal thickness of the eyes, or eyes that were unacceptably stained with fluorescein (score higher than 0.5), indicating the cornea to be permeable, or eyes that showed any other signs of damage, were rejected as test eyes and replaced, if necessary. Four eyes were selected for testing.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 1 control eye treated with isotonic saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.03 mL - Duration of treatment / exposure:
- 10 sec
- Observation period (in vivo):
- 240 min
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): each was washed out with 20 mL of isotonic saline; after rinsing the eyes were examined at 0, 30, 75, 120, 180 and 240 min.
ENDPOINTS MEASURED
Corneal opacity, swelling, fluorescein retention and morphological effects
SCORING SYSTEM
- Corneal swelling: [(CT at t - CT at t=0)/ CT at t=0] × 100%, where CT: corneal thickness
- Corneal opacity: Opacity degree of density (area most dense taken for scoring)
0 = no opacity; 0.5 = very faint opacity; 1 = scattered or diffuse areas, details of iris clearly visible; 2 = easily discernible translucent area, details of iris slightly obscured; 3 = severe corneal opacity, no specific details of iris visible, size of pupil barely discernible; 4 = complete corneal opacity, iris invisible
TOOL USED TO ASSESS SCORE: Slit lamp microscope
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Remarks:
- after 240 min
- Run / experiment:
- 1
- Value:
- 39
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- after 240 min
- Run / experiment:
- 2
- Value:
- 44
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Remarks:
- after 240 min
- Run / experiment:
- 3
- Value:
- 41
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- after 240 min
- Run / experiment:
- 1
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- after 240 min
- Run / experiment:
- 2
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- after 240 min
- Run / experiment:
- 3
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Remarks:
- after 30 min
- Run / experiment:
- 1
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Remarks:
- after 30 min
- Run / experiment:
- 2
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Remarks:
- after 30 min
- Run / experiment:
- 3
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- n-Butyl-S-lactate is highly irritating and possibly corrosive to the eye of chicken when tested with a single application under the conditions of the present test. On the basis of these results, it is recommended not to perform the standard rabbit eye irritation test with n-butyl-S-lactate in rabbits, but to classify the test substance as an eye irritant Category 1.
- Executive summary:
n-Butyl-S-lactate was examined for eye irritating/corrosive potential in an ex vivo bioassay, the enucleated eye test with chicken eyes (CEET). The chicken eyes were obtained from slaughter animals for human consumption. Four chicken eyes were used (one as a control, washed with physiological saline). Although the study was performed before the adoption of the OECD guideline 438 for this test, the design was very similar to the design proposed in the aforementioned guideline. The sample caused severe corneal swelling, severe corneal opacity and severe fluorescein retention of damaged corneal epithelium in the test eyes. On the basis of the results obtained with this investigation and according to the scheme for (EC) classification applied, it is concluded that n-butyl-S-lactate is severely irritating and possibly corrosive to eyes. On the basis of these results, it is recommended not to perform the standard rabbit eye irritation test with n-butyl-S-lactate in rabbits, but to classify the test substance as an eye irritant Category 1.
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