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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 March - 17 May 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted (according to study report) 1987
- Deviations:
- yes
- Remarks:
- Limit dose higher than 2000 mg/kg bw/day (5000 mg/kg bw/day)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- 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:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina, USA
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: approximately 9 weeks (males), 10 weeks (females)
- Weight at study initiation: 290.2 g (males), 225.5 g (females)
- Housing: individually in stainless steel, wire-mesh cages suspended above cage boards
- Diet: water, ad libitum
- Water: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shaved back from the scapular to the lumbar region (approximately 5 cm x 7.4 cm, 37 cm²)
- Type of wrap if used: test substance was covered with a 2-ply gauze patch. Rats were then wrapped with stretch gauze bandage and self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 5000 mg/kg bw moistened with 0.6 mL of deionized water
- For solids, paste formed: yes
- Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw/day
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and clinical signs of illness, injury, dermal irritation and abnormal behavior were made daily (weekends excluded for dermal irritation). Body weight was determined prior to treatment and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight other: dermal irritation (Draize score)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured during the 14 days test period.
- Clinical signs:
- other: No clinical signs of systemic toxicity were observed during the study period. Two male rats exhibited stained fur/skin or ocular discharge after test substance removal. These clinical signs are commonly seen in wrapped rats and therefore are not considere
- Gross pathology:
- Gross pathology did not reveal any abnormalities.
- Other findings:
- - Other observations: Erythema (score of 1 or 2) was observed in 9 rats and ulceration was observed in 4 rats on the day after application of the test substance. The erythema and ulceration may have been due to the gauze pads adhering to the test sites at the time of washing. No dermal irritation was observed in the remaining rat.
Any other information on results incl. tables
Table 1. Table for acute dermal toxicity. | ||||
Dose [mg/kg bw] |
Toxicological results* | Duration of clinical signs | Time of death | Mortality (%) |
Males | ||||
5000 | 0/5/5 | stained (red) skin/fur chin, ulceration, black discharge eye bilateral, Day 1 | / | 0 |
Females | ||||
5000 | 0/1/5 | Hair loss (forelimb bilateral), Day 11 -14 | / | 0 |
LD50 = > 5000 mg/kg bw | ||||
* first number = number of dead animals | ||||
second number = number of animals with clinical signs | ||||
third number = number of animals used |
Table 1. Results of skin irritation parameters (Draize score) | ||||||||||||||||||||
Observation time | Rabbit no. | |||||||||||||||||||
1 (male) | 2 (male) | 3 (male) | 4 (male) | 5 (male) | 6 (female) | 7 (female) | 8 (female) | 9 (female) | 10 (female) | |||||||||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
1 Day | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 2 | 0 |
Day 2-14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- In this acute dermal toxicity study a LD50 value of > 5000 mg/kg bw was determined in male and female rats.
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