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EC number: 617-769-9 | CAS number: 858956-08-8
- 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:
- 6 - 16 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted: 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
- EC Number:
- 617-769-9
- Cas Number:
- 858956-08-8
- Molecular formula:
- C8H8ClN3O2
- IUPAC Name:
- 6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania, USA
- Age at study initiation: adult
- Weight at study initiation: 3830 g, 3024 g and 2979 g
- Housing: individual housed in stainless steel wire-mesh cages suspended above cage boards
- Diet: approximately 125 g of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with 0.4 mL deionized water (a thick paste was formed)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
- Number of animals:
- 1 male (initial test)
2 males (confirmatory test) - Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the scapular to the lumbar region of the back
- Type of wrap if used: The treated skin was covered with a 2-ply gauze pad and held in place with with non-irritating tape. The trunk of each rabbit was wrapped with porous tape. The tape was further secured with waterproof tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with warm water and gently patted dry.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h (The rabbit that was initially treated was also examined immediately after test substance removal. )
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritant / corrosive response data:
- Erythema (score of 2 and 1) but no edema was observed on the test site of the first rabbit at 0 minutes and 60 minutes after test substance removal, respectively. At later time points, no skin reactions were observed. The remaining animals did not show signs indicative for dermal irritation during the study.
- Other effects:
- - Other adverse systemic effects: No clinical signs of toxicity were observed and no body weight loss occurred.
Any other information on results incl. tables
Table 1: Results of skin irritation study
Observation time |
Rabbit no. |
|||||
1 * |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
0 h (Immediately after exposure) |
2 |
0 |
- |
- |
- |
- |
1 h |
1 |
0 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
0.6 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Mean value |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
*Initial rabbit tested
Table 2: Body weight
Rabbit number |
sex |
Initial weight (g) |
Final weight (g) |
1 |
male |
2830 |
2834 |
2 |
male |
3024 |
3053 |
3 |
male |
2976 |
3046 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits. Mild erythema were only observed in one animal immediately after the exposure period and 1h after exposure, but were fully reversible within 24 h. No oedema were reported at any time point.
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