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EC number: 939-200-6 | CAS number: -
- 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:
- key study
- Study period:
- 27th May 2013 to 15th August 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and OECD Guideline.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium Isobutyrate Solution
- IUPAC Name:
- Sodium Isobutyrate Solution
- Reference substance name:
- Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate
- EC Number:
- 939-200-6
- IUPAC Name:
- Reaction mass of lithium 3-hydroxy-2,2,4-trimethylpentanoate and lithium isobutyrate and sodium 3-hydroxy-2,2,4-trimethylpentanoate and sodium isobutyrate
- Test material form:
- other: semi liquid
- Details on test material:
- - Name of test material (as cited in study report): Sodium Isobutyrate Solution
- Physical state: Light yellow semi liquid
- Analytical purity: 86.5%
- Composition of test material: confidential information
- Lot/batch No.: W195_02
- Expiration date of the lot/batch: 17th October 2013
- Storage condition of test material: Controlled room temperature (15-25°C, below 70% relative himidity).
- Other: The pH was assessed to identify if it was extreme prior to application to the animals. The pH was found to be 6.5, so the test test item was permitted for use in th the animal studies.
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: S&K-LAP Kft., 2173 Kartal, Czászár út 135, Hungary.
- Age at study initiation: approximately 12 weeks old.
- Weight at study initiation: 2766 - 3236g
- Housing: Rabbits were individually housed in AAALAC approved metal wire cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet (e.g. ad libitum): UNI diet for rabbits ad libitum.
- Water (e.g. ad libitum): Municipal tap water ad libitum from an automatic system.
- Acclimation period: At least 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.1°C - 21.6°C.
- Humidity (%): 37 - 72%
- Air changes (per hr): 15-20 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours daily (from 6am to 6pm).
IN-LIFE DATES: From: 4th June 2013 To: 13th June 2013.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Contralateral eye of test animal acted as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL - Duration of treatment / exposure:
- 24 hours.
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated eyes were rinsed with physiological saline solution.
- Time after start of exposure: 24 hours.
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize and OECD 405.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all test animals
- Time point:
- other: One hour after application
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: all test animals
- Time point:
- other: One hour after application
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: Discharge
- Basis:
- other: all test animals
- Time point:
- other: One hour after application
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all test animals
- Time point:
- other: 24 hours after treatment
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: all test animals
- Time point:
- other: 24 hours after treatment
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: Discharge
- Basis:
- other: all test animals
- Time point:
- other: 24 hours after treatment
- Score:
- > 1 - < 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all test animals
- Time point:
- other: 48 hours after treatment
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2 test animals
- Time point:
- other: 48 hours after application
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: Discharge
- Basis:
- animal: 2 test animals
- Time point:
- other: 48 hours after treatment
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all test animals
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- other: all test animals
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all test animals
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- At 72 hours after treatment, no clinical signs or conjunctival or corneal effects were observed.
An Initial Pain Reaction score of 1 was observed in 2 animals tested. - Other effects:
- There was no mortality observed during the study.
The body weights of the animals were considered to be within the normal range of variability.
During the daily general examinations, there were no clinical signs observed that could be related to treatment and the general state and behaviour of the animals were normal throughout the study period.
During the study, the control eye of each animal was symptom-free.
Any other information on results incl. tables
Mean Values of Eye Irritation:
Animal |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
|||
1 |
0.00 |
0.00 |
1.00 |
0.67 |
1.00 |
2 |
0.00 |
0.00 |
1.00 |
0.33 |
0.33 |
3 |
0.00 |
0.00 |
1.00 |
1.00 |
1.33 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item, Sodium Isobutyrate Solution, applied to rabbit eye mucosa caused conjunctival irritatnt effects at one hour which were reduced at 48 hours after application. The effects were fully reversible within 72 hours.
Under the conditions of this study and based on its results, the test material, Sodium Isobutyrate Solution is not considered to be an eye irritant and does not require classification according to Regulation (EC) No 1272/2008. - Executive summary:
An acute eye irritation study was conducted to determine the potential of Sodium Isobutyrate Solution to cause eye irritation in New Zealand White rabbits. The study was conducted in accordance with OECD Guideline 405 and was scored according to the Draize method. Three male test animals were used in the study, with the test material placed in the conjunctival sac of the left eye of each animal, with the right eye serving as the control. A single volume of 0.1 mL of test material was administered as a single dose.
The eyes were examined 1, 24, 48 and 72 hours after application of the test material. An Initial Pain Reaction of 1 was observed in 2 animals and one hour after application, conjunctival redness (score of 2), chemosis (score of 2) and discharge (score of 2 and 3) were observed in the treated eye of all test animals. 24 hours after application, conjunctival redness (score of 2), chemosis (score of 1 or 2) and discharge (score of 1, 2 and 3) were observed in the treated eye of all test animals. 48 hours after treatment, conjunctival redness (score of 1) was observed in all animals. Chemosis (score 1) and discharge (score of 1) were sen in 2 of the test animals.
In the absence of clinical signs 72 hours after treatment, the study was terminated. At all times during the study, the control eye of each animal was symptom free and the general state and behaviour of the animals was normal for the duration of the study.
Under the conditions of this study and based on its results, the test material, Sodium Isobutyrate Solution is not considered to be an eye irritant and does not require classification according to Regulation (EC) No 1272/2008.
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