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Diss Factsheets
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EC number: 604-721-7 | CAS number: 150114-71-9
- 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
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June 2001 to 30 August 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Acute Dermal Toxicity Study, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-amino-3,6-dichloropyridine-2-carboxylic acid
- EC Number:
- 604-721-7
- Cas Number:
- 150114-71-9
- Molecular formula:
- C6H4Cl2N2O2
- IUPAC Name:
- 4-amino-3,6-dichloropyridine-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: tan powder
Constituent 1
- Specific details on test material used for the study:
- Purity: 94.5%
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: ca. 8 weeks
- Weight at study initiation: 122 - 176 g
- Housing: animals were housed two or three per cage in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40 - 70 % (relative)
- Air changes: 12 - 15 air changes per hour
- Photoperiod: 12 hours of darkness / 12 hours of light (06:00 to 18:00)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: the test material was moistened with 0.5 % aqueous methylcellulose
- Details on dermal exposure:
- The dorsal side of the trunk of each rat was clipped free of fur the day prior to application of the test material. The test material, moistened with 0.3 mL of 0.5 % aqueous methylcellulose, was administered to the back of the rats (approximately 10 % of the surface area of the rats) and covered with a 6 x 6 cm gauze/cotton patch. The gauze patch was held in place by elastic tape and wrap. The wrappings were removed after approximately a 24-hour exposure period and observations were recorded for irritation at the application site. The skin was wiped thoroughly with a water-moistened soft disposable towel and dried with a soft disposable towel.
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A Detailed Clinical Observation (DCO) was conducted for all rats prior to test material administration for comparison with the observations recorded throughout the study. Animals were observed a minimum of two times on the day of treatment. A DCO was done each day (including weekends and holidays) during the study. Hand-held and open-field observations included a careful physical examination. The rats were weighed pre-study, the day of treatment and on days 2, 8, and 15.
- Necropsy of survivors performed: Yes, necropsy was performed on all animals. Animals were anaesthetised by inhalation of carbon dioxide and euthanised by decapitation after clamping of the trachea.
- Other examinations performed: The eyes were examined in situ using a moistened glass microscope slide applied to the corneal surface. Following inspection of the externum and body orifices, the nasal, cranial, oral, thoracic, and abdominal cavities were opened and the visceral organs were examined both in situ and following dissection, and tissues were not saved. - Statistics:
- Means and standard deviations were calculated for body weights. The data were evaluated for statistical outliers by a sequential test (Grubbs, 1969); however, outliers were not routinely excluded from statistical analysis.
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:
- All animals survived the two-week observation period.
- Clinical signs:
- other: Clinical observations consisted of perioral soiling in one male and two females on test day 1 or 2 and periocular soiling in one male on test day 1. There was also an abrasion or scratches observed on the dermal test site of one male and one female rat fr
- Gross pathology:
- There were no gross pathologic observations.
Any other information on results incl. tables
Table 1: Mean body weights (g)
Days on test |
|||||
Sex |
-1 |
1 |
2 |
8 |
15 |
Male |
168.9 |
173.2 |
162.8 |
200.8 |
227.3 |
Female |
127.1 |
128.6 |
118.0 |
137.6 |
146.6 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 of the test material in male and female Fischer 344 rats was greater than 5000 mg/kg.
- Executive summary:
The acute dermal toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF (2000).
During the study, five male and five female Fischer 344 rats received a single 24-hour exposure of 5000 mg/kg body weight of test material moistened with 0.5 % aqueous methylcellulose. Parameters evaluated during the two-week observation period included body weights, detailed clinical observations, and gross pathological changes.
All animals survived the two-week observation period. Clinical observations consisted of perioral soiling in one male and two females on test day 1 or 2 and periocular soiling in one male on test day 1. There was also an abrasion or scratches observed on the dermal test site of one male and one female rat from test day’s 2-5 or test day 4, respectively. The test material dried and adhered to these two animals, thus causing the abrasion/scratches during test material removal. All animals lost weight by test day 2, but gained weight over the remainder of the study. There were no gross pathologic observations.
Therefore, under the conditions of this study, the acute dermal LD50 of test material in male and female Fischer 344 rats was greater than 5000 mg/kg bw.
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