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EC number: 600-588-4 | CAS number: 104617-50-7
- 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:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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:
- N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide
- EC Number:
- 600-588-4
- Cas Number:
- 104617-50-7
- Molecular formula:
- C9 H13 O N3 S x HBr
- IUPAC Name:
- N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 48 - 59 weeks
- Weight at study initiation: 4.4 - 6 kg
- Housing: Individual accommodation in stainless steel wire cages, with a floor area of
3878 cm2.
- Feed: Standardized pelleted feed 9980 (Altromin, Lage). Certificates of analysis relating to nutritional content and presence of contaminants of the batches used are kept in the archives of the Laboratory Animal Services Unit of Boehringer lngelheim.
- drinking water: Filtered, demineralized water of drinking quality was adjusted to pH 2.6 ± 0.2 with hydrochloric acid and was freely available to the animals.
- Acclimation period: > 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3 -1 °C
- Relative Humidity (%): 55 (50 - 65) %
- Photoperiod (hrs dark / hrs light): A cycle of 12:12 hrs. light: darkness was maintained
IN-LIFE DATES: From: To: 27.03.1995 - 31.03.1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg SND 919 CL2 Y Precursor 1 (2-Amino-6-acetylamino-4,5,6,7- tetrahydrobenzothiazole x HBr) were instilled into the conjunctiva! sac of the right eyes of the rabbits, while the left eyes served as controls.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- no other effects
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. to CLP
- Conclusions:
- SND 919 CL2 Y Precursor 1 = SND 919 Thiazol was evaluated to be not eye irritating.
- Executive summary:
Under the conditions described in this report, 100 mg SND 919 CL2 Y Precursor 1 (2-Amino-6-acetylamino-4,5,6,7-tetrahydrobenzothiazole x HBr) = SND 919 Thiazol were instilled into the conjunctival sac of the right eyes of New Zealand White rabbits. 1 h to 24 h post administration, only slight redness of the conjunctiva was seen in two of the four rabbits.
It was no longer evident 48 h post administration. No other findings were recorded. Mean maximal score for conjunctival redness was 0.25 - 0.5.
No special labelling is necessary in accordance with German regulations "Gefahrstoffverordnung" (Dangerous Compounds Regulations ),
since the mean score for conjunctival redness was below 2.5.
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