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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1994-06-14 to 1994-09-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. 2-ethylhexyl lactate used as read-across partner.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 186817-80-1
- Cas Number:
- 186817-80-1
- IUPAC Name:
- 186817-80-1
- Reference substance name:
- 2-ethylhexyl lactate
- EC Number:
- 228-503-2
- EC Name:
- 2-ethylhexyl lactate
- Cas Number:
- 6283-86-9
- Molecular formula:
- C11H22O3
- IUPAC Name:
- 2-ethylhexyl 2-hydroxypropanoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-ethylhexyl-lactate
- Chemical name: (S)-2-hydroxypropanoic acid (R,S)-2-ethylhexylester
- Physical state: clear, colourless liquid
- Analytical purity: min. 97 %
- Storage condition of test material: Ambient
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Instituut BV, Someren, the Netherlands
- Age at study initiation: young adult, sex not determined
- Date of arrival: 1994-05-18 (animal number 29 and 30) or 1994-06-01 (animal number 37)
- Date of dosing: 1994-06-14 (animal number 37) and 1994-06-15 (animal number 29 and 30)
- Weight at study initiation: 2250-2940 g
- Housing: individually in a stainless steel cage, fitted with a perforated floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 and 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 42-82.5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 1994-06-01 to 1994-07-08
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated, serving as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): min. 97 % - Duration of treatment / exposure:
- An amount of 0.1 mL of the test substance was instilled in the conjunctival cul-de-sac of the right eye. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours; 7, 14, 21 and 25 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Pre-test:
Prior to the in vivo testing, the test substance was also examined in the Chicken Enucleated Eye Test (CEET). The test substance caused severe reactions in the CEET.
Main Test:
Based on the results from this CEET it was decided to start with one rabbit. As severe signs of irritation were not observed in this rabbit, it was decided to continue the test with additional two rabbits.
SCORING SYSTEM: See Table 1.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The cornea score for two animals was 0 after 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24 , 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The iris score of two animals was 0 after 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The conjunctivae score of two animals was 0 after 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: The chemosis score of two animals was 0 after 14 days
- Irritation parameter:
- other: ocular discharge
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.55
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The ocular discharge score of two animals was 0 after 72 hours
- Irritant / corrosive response data:
- At 1 hour after treatment, the eye effects observed in the three rabbits consisted of slight corneal opaicity, slight iritis, slight redness and moderate swelling of the conjunctivae, and severe ocular discharge. At 24 hours after treatment, the eye effects observed consisted of slight or moderate corneal opacity, slight iritis, moderate or severe redness and slight swelling of the conjunctivae, and slight or severe ocular discharge. At 48 hours after treatment, the eye effects observed consisted of slight or moderate corneal opacity, slight iritis (two rabbits), moderate or severe redness and slight or moderate swelling of the conjunctivae, and slight or severe ocular discharge. At 72 hours after treatment, the eye effects observed consisted of slight or moderate corneal opacity, slight iritis (one rabbit), slight, moderate or severe redness and slight or moderate swelling of the conjunctivae, and moderate ocular discharge (one rabbit). At 7 days after treatment, the eye effects observed consisted of slight corneal opacity and vascularization of the cornea in one rabbit, and slight redness and slight swelling of the conjunctivae in two rabbits. At 14 days after treatment, eye effects were still observed in one rabbit and consisted of slight corneal opacity, vascularisation of the cornea, and slight redness and slight swelling of the conjunctivae. At 21 days, these eye effects except minor vascularisation of the cornea had cleared completely. At 25 days, this eye effect had also cleared completely.
- Other effects:
- N.A.
Any other information on results incl. tables
Table 2: Individual scores awarded to the ocular lesions elicited by 2-etyhlhexyl lactate | |||||
rabbit number | corneal opacity | iris effects | conjunctivae | ocular discharge | |
redness | chemosis | ||||
after one hour | |||||
37 | 1 (4) | 1 | 1 | 2 | 3 |
29 | 1 (4) | 1 | 1 | 2 | 3 |
30 | 1 (4) | 1 | 1 | 2 | 3 |
after 24 hours | |||||
37 | 2 (4) | 1 | 3 | 1 | 3 |
29 | 1 (4) | 1 | 3 | 1 | 3 |
30 | 2 (2) | 1 | 2 | 1 | 1 |
after 48 hours | |||||
37 | 2 (2) | 1 | 3 | 1 | 1 |
29 | 2 (2) | 1 | 3 | 2 | 3 |
30 | 1 (2) | 0 | 2 | 1 | 1 |
after 72 hours | |||||
37 | 2 (2) | 0 | 2 | 1 | 0 |
29 | 2 (4) | 1 | 3 | 2 | 2 |
30 | 1 (1) | 0 | 1 | 1 | 0 |
after 7 days | |||||
37 | 0 | 0 | 1 | 1 | 0 |
29 | 1 (4)* | 0 | 1 | 1 | 0 |
30 | 0 | 0 | 0 | 0 | 0 |
after 14 days | |||||
37/30 | 0 | 0 | 0 | 0 | 0 |
29 | 1 (3)* | 0 | 1 | 1 | 0 |
after 21 days | |||||
29 | 0* | 0 | 0 | 0 | 0 |
after 25 days | |||||
29 | 0 | 0 | 0 | 0 | 0 |
(): area of opacity, 1= one quarter (or less) but not zero, 2= half area, 3= three quarter, 4= entire area | |||||
*= vascularization of the cornea; the degree diminshed gradually |
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 2-ethylhexyl-lactate is distinctly irritating for the eyes of rabbits.
- Executive summary:
In a primary eye irritation study (OECD 405), 0.1 mL of 2-etyhlhexyl lactate (purity ≥ 97 %) was instilled into the conjunctival sac of the right eye of three young adult New Zealand White rabbits. Animals then were observed for a maximum of 25 days. Irritation was scored by the method according to OECD guideline 405. The test substance caused moderate corneal opacity, slight iritis, moderate or severe redness and moderate swelling of the conjunctivae, and severe ocular discharge in the three rabbits. These adverse irritation effects were fully reversible within 21 days. In accordance to the CLP regulation 2-etyhlhexyl lactate needs to be classified in Category 2 (irritating to eyes).
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