Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 261-867-0 | CAS number: 59703-00-3
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from review article or handbook
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- IUCLID Dataset
- Author:
- BASF AG
- Year:
- 1 992
- Bibliographic source:
- IUCLID Dataset- BASF AG- 08-DEC-1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- An eye irritation study of Theophylline was conducted on White Vienna rabbits in accordance with OECD Guide-line 405 to observe its effects on rabbits’ eye.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Theophylline
- EC Number:
- 200-385-7
- EC Name:
- Theophylline
- Cas Number:
- 58-55-9
- Molecular formula:
- C7H8N4O2
- IUPAC Name:
- 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Theophylline
- Molecular formula: C7H8N4O2
- Molecular weight: 180.166 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Theophylline
- Molecular formula: C7H8N4O2
- Molecular weight: 180.166 g/mol
- Substance type: Organic
- Physical state: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- not specified
- Amount / concentration applied:
- 1mL
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 1, 24, 48, and 72 hours and at 8 days after instillation
- Number of animals or in vitro replicates:
- 3 (male)
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was placed into the right conjunctival sac of each of 3 male White Vienna rabbits
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).
- Other effects:
- Very slight corneal opacity was observed in 1-2 rabbits up to day 8. Slight to well-defined conjunctival redness and conjunctival swellings were observed in all 3 rabbits up to 72h and 48h, respectively. On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time. The findings were reversible in 2 of the 3 animals
Since, the findings were reversible in 2 of the 3 animals, therefore Theophylline (CAS No:-58-55-9) was considered to be not irritating to the eyes of White Vienna rabbits. - Executive summary:
An eye irritation study was performed in 3 White Vienna rabbits male for the test chemical Theophylline(CAS No:-58-55-9) in accordance with OECD Guide-line 405 "Acute Eye Irritation/Corrosion".
The test substance was placed into the right conjunctival sac of each of 3 male White Vienna rabbits.The eyes were not rinsed. Scoring was made at 1, 24, 48, and 72 hours and at 8 days after instillation.Very slight corneal opacity was observed in 1-2 rabbits up to day 8. Slight to well-defined conjunctival redness and conjunctival swellings were observed in all 3 rabbits up to 72h and 48h, respectively. Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time. The findings were reversible in 2 of the 3 animals
Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time. The findings were reversible in 2 of the 3 animals
Since, the findings were reversible in 2 of the 3 animals, therefore Theophylline (CAS No:-58-55-9) was considered to be not irritating to the eyes of White Vienna rabbits.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.