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EC number: 618-507-6 | CAS number: 90213-66-4
- 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:
- 05-Dec-2007 to 13-DEC-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4-dichloro-7H-pyrrolo[2,3-d]pyrimidine
- EC Number:
- 618-507-6
- Cas Number:
- 90213-66-4
- Molecular formula:
- C6H3Cl2N3
- IUPAC Name:
- 2,4-dichloro-7H-pyrrolo[2,3-d]pyrimidine
- Test material form:
- solid
- Details on test material:
- White to yellow tan colour
Constituent 1
- Specific details on test material used for the study:
- Identification: CP-902684
Description: Solid; tan
Batch Number: E010005632 or 166-TNN-73
Purity: 98%
Stability of Test Item: Stable under storage conditions.
Expiry Date: 21-MAR-2009
Storage Conditions: At room temperature (range of 20 ± 5 °C, provided by RCC), light protected.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals: Young Adult New Zealand White Rabbit, SPF
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst / The Netherlands, Postbus 6174, NL-5960, AD Horst / The Netherlands
Number of Animals per Test: 3 (Animals of both sexes were used)
Age when treated: 12 weeks (male), 12 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination, Only animals without any visual signs of illness were used for the study.
Allocation: Male No. 70, Female Nos. 71,72
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 17-23 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Ftillinsdorf) and haysticks 4642 (batch no. 36/07, Provimi Kliba AG) were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 61/07) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
Water: Community tap water from Füllinsdorf ad libitum.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 0.5 g (per animal) of CP-902684 was weighed as delivered by the Sponsor and then moistened with approximately 0.5 mL of purified water before application.
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g (per animal) of CP-902684 was weighed as delivered by the Sponsor and then moistened with approximately 0.5 mL of purified water before application.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 1 male/2 females
- Details on study design:
- TEST SITE
- Area of exposure: intact left flank
- % coverage: 100 cm2 (10cm x 10 cm)
- Type of wrap if used: On the day of treatment, 0.5 g of CP-902684 was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm) This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 hours, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
OBSERVATION TIME POINTS
Skin observation time points: 1, 24, 48 and 72 hours after exposure
SCORING SYSTEM:
- Method of calculation: The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythemaJeschar grades and for oedema grades, separately. An animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2
animals are positive for the same endpoint (erythema/eschar or oedema). The Cumulative Scores for the Skin Irritation Scores were calculated too and represent the sum of all numerical scores for each animal at each time point. The resulting Mean Cumulative Skin Irritation Score was calculated for all animals at each time point. The Primary Irritation Index (P.I.I.) was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing by the number of available figures.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Irritation: The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Corrosion: Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- Viability / Mortality / Clinical Signs: No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Coloration: No staining produced by the test item of the treated skin was observed.
Body Weights: there were no body weigh losses observed
Any other information on results incl. tables
The animals were not sacrificed. No signs of irritation were observed on the treated skin following the application of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), CP-902684 is considered to be "not irritating" to rabbit skin. According to Draize classification criteria CP-902684 is considered to be "not irritant" to rabbit skin (P.I.I. = 0.00).
- Executive summary:
The primary skin irritation potential of CP-902684 was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The primary irritation index was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation index was 0.00 (max. 8.0). The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), CP-902684 is considered to be "not irritating" to rabbit skin. According to Draize classification criteria CP-902684 is considered to be "not irritant" to rabbit skin (P.1.1. = 0.00).
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.
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