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EC number: 613-975-8 | CAS number: 666816-98-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Aug 2003 - 12 Sep 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 8-bromo-7-(but-2-yn-1-yl)-3-methyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione
- EC Number:
- 613-975-8
- Cas Number:
- 666816-98-4
- Molecular formula:
- C10-H9-Br-N4-O2
- IUPAC Name:
- 8-bromo-7-(but-2-yn-1-yl)-3-methyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Laboratory Service of Boehringer Ingelheim
Pharma GmbH & Co. KG
- Age at study initiation: approximately 4 months
- Weight at study initiation: 3.3 - 3.6 kg (day of application)
- Housing: Rabbits were housed individually in solid wire cages.Housing in room 33, application in room 40 (building N81)
-Dry food and municipal drinking water were supplied ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 45 - 75%
- Air changes (per hr): approximately 10 air changes per hour
- Light/darkness cycle: 12/12 h, with light cycle from 6.00 h to 18.00 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- Approximately 0.5 g
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1h, 24, 48h and 72h
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dermal skin
- The area to be treated is about 6 cm2
- occluded by muslin
- The shaved and marked skin areas were treated with the test item and occluded by muslin
tissue and fixed by a non-skin-irritating plaster.
REMOVAL OF TEST SUBSTANCE
- At the end of the indicated exposure times, the respective skin area was washed with
demineralized water to remove the test item.
- According to the test strategy described in OECD Guideline 404, only one animal was treated
initially (Group 1, initial test). Sequentially, the test item was administered to three skin sites
for 3 min (area 1), 1 h (area 2), and 4 h (area 3), respectively. Administration to the next skin
area was only performed in the absence of serious skin alterations in the previous one. When
no serious skin alterations occurred subsequent to 4 h of exposure on the first rabbit, the test
item was administered to two more animals (Group 2, confirmatory test) on the following day
for 4 h at a single site only.
OBSERVATION TIME POINTS
- 1 h, 24 h, 48 h, and 72 h
SCORING SYSTEM:
- They were evaluated according to the criteria given in OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1H/24H/48H/72H
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24H
- Remarks on result:
- other: In summary, BI 1344 BZ/CD 164 had no corrosive, but a very slight, transient irritating effect. Minimal, barely perceptible erythema, but no edema, was seen in one out of three animals exclusively at 1 h only following exposure for either 1 h or 4 h and
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h/24h/48h/72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1h/24h/48h/72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h/24h/48h/72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1h/24h/48h/72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h/24h/48h/72h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- Under the conditions of the present study, BI 1344 BZ/CD 164 had no corrosive, but a very
slight, transient irritating effect. Minimal, barely perceptible erythema, but no edema, was
seen in one out of three animals exclusively at 1 h only following exposure for either 1 h or 4
h and returning to normal within 24 h. There were no signs of systemic side effects or of skin
alterations beyond the area of exposure. Thus, according to the Globally Harmonized Hazard
Classification and Labeling Scheme (GHS), the test item BI 1344 BZ/CD 164 is not
classified.
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