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EC number: 611-909-2 | CAS number: 59875-04-6
- 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-butyrylalanine
- EC Number:
- 611-909-2
- Cas Number:
- 59875-04-6
- Molecular formula:
- C7 H13 N O3
- IUPAC Name:
- N-butyrylalanine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 1.9 - 2.5 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- eye was not rinsed after instillation of the test item
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 4 to 21 days after instillation
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: for details see section 'irritant/corrosive reponse data'
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: for details see section 'irritant/corrosive reponse data'
- Irritation parameter:
- iris score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: for details see section 'irritant/corrosive reponse data'
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 18 days
- Remarks on result:
- other: for details see section 'irritant/corrosive reponse data'
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.6
- Max. score:
- 4
- Remarks on result:
- other: for details see section 'irritant/corrosive reponse data'
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 18 days
- Remarks on result:
- other: for details see section 'irritant/corrosive reponse data'
- Irritant / corrosive response data:
- Under the present test conditions a single application of 1 00 mg Butanoylalanin per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Corneal opacity
animal no. 1: 1 to 72 hours after instillation (grade 3), 4 to 16 days after Instillation (grade 2) and 17 to 21 days (grade 1);
animal no. 2: 1 and 24 hours after instillation (grade 3), 48 hours to 5 days after instillation (grade 4) and 6 to 21 days (grade 3);
animal no. 3: 1 hour to 5 days after instillation (grade 3), 6 to 14 days after instillation (grade 2) and 15 to 21 days (grade 1 ).
The fluorescein test performed after 24 hours revealed corneal staining in all 3 rabbits (whole surface). The fluorescein test performed after 7 days revealed corneal staining in animal no. 1 (3/4 of the corneal surface) and animal nos. 2 and 3 (whole surface).
The fluorescein tests performed after 14 days revealed corneal staining in animal no. 1 (3/4 of the corneal surface), in animal no. 2 (whole surface) and in animal no. 3 (3/4 of the corneal surface) . The fluorescein tests performed after 21 days revealed corneal staining in animal no. 1 ( 1/2 of the corneal surface), in animal no. 2 (whole surface) and in animal no. 3 (1 /4 of the corneal surface).
An irritation of the iris (grade 2) was observed in all animals 1 hour to 5 days after instillation, in animal no. 1 until 6 days, in animal no. 2 until 21 days after Instillation, (grade 1) in animal no. one 7 to 21 days and in animal no. three 6 to 16 days after Instillation.
Conjunctival redness (grade 1 ) was observed in all three animals 1 hour to 6 days after instillation, in animal no. 2 until 17 days and in animal no. 3 until 14 days after instillation.
Conjunctival chemosis
animal no. 1: 1 hour and 48 hours after instillation (grade 1 ), 24 hours after instillation (grade 2);
animal no. 2: 1 hour and 72 hours to 17 days after instillation (grade 1 ), 24 and 48 hours after instillation (grade. 2);
animal no. 3: 1 hour and 72 hours to 6 days after instillation (grade 1 ), 24 and 48 hours after nstillation (grade 2).
Further observations
Loss of hair at the upper and lower Iids was observed in rabbit no. one 7 to 1 6 days after instillation, in rabbit no. two 7 to 21 days and in rabbit no. three 7 to 11 days after instillation.
Whitish deposits in the conjunctival sac (probably pus) were noted in one rabbit (no. 2) 7 to 9 days after instillation. - Other effects:
- No systemic intolerance reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information
- Executive summary:
In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 male rabbits each. Eye irritation was assessed 1, 24, 48 and 72 hours and 4 to 21 days after instillation using the Draize scale. In this study strong irritation was seen as corneal opacity (up to grade 4 of max. 4), effects on iris (up to grade 2 of max. 2), conjunctional redness (up to grade 1 of max. 3) and conjunctional chemosis (up to grade 2 of max. 4). Partly the effects (cornea and iris) appeared to be not reversible within the 21 days observation period. Loss of hair at the upper and lower eye lid and whitish deposits in the conjunctival sac became obvious. No systemic intolerance reactions were observed.
According to classification criteria Butanoylalanin causes serious damage to rabbit's eyes.
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