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EC number: 401-610-3 | CAS number: 122012-52-6 GENIPLEX A
- 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:
- until 1985-09-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Noakes, D.N. and Sanderson, D.M. "A method for determining, the dermal toxicity of pesticides", Brit. J. Ind. Ned., 1969
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The test item at a concentration of 300 mg/ml in corn oil was applied at a dose level of 2100 mg/kg body weight for 24 hours under occlusion, to the shaved backs of a group of 5 male and 5 female rats and the animals observed for 14 days after treatment.
Treatment was carried out according to the procedure described by Noakes and Sanderson (Noakes, D.N. and Sanderson, D.M. "A method for determining, the dermal toxicity of pesticides", Brit. J. Ind. Ned., 1969) - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diamminediisocyanatozinc
- EC Number:
- 401-610-3
- EC Name:
- Diamminediisocyanatozinc
- Cas Number:
- 122012-52-6
- Molecular formula:
- C2H6N4O2Zn
- IUPAC Name:
- copper(2+) bis(carbonylazanide) diamine
- Test material form:
- solid: particulate/powder
- Remarks:
- white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Charles River COBS CD Sprague-Dawley rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd. Manston Road, Margate, Kent
- Age at study initiation: 56-day old male and 76-day old female rats
- Weight at study initiation: On the day of treatment (Day 1) body weights ranged from 277 g to 304 g for males and 229 g to 252 g for females.
- Fasting period before study: no
- Housing: Rats were housed by sex for each dose level in galvanised metal, all mesh cages. For treatment, they were distributed into 2 groups each comprising 5 males and 5 females (a total of 20 animals) using a randomised block design based upon body weight to give groups of similar mean body weight for each sex and similar weight distribution.
- Diet (e.g. ad libitum): free access to Modified Expanded S.Q.C. Rat and Mouse Diet (BP SDS Ltd., Stepfield, Witham, Essex)
- Water (e.g. ad libitum): tap water ad libitum
Contaminants in diet and water were monitored in accordance with the standard operating procedures used within the Toxicology Department and were found to be within acceptable limits.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature in the animal room ranged from 19°C to 23°C.
- Humidity (%): Relative humidity in the animal room ranged from 45% to 62%.
- Photoperiod (hrs dark / hrs light): There was a 12 hour artificial light photo-period from 7 am to 7 pm.
IN-LIFE DATES: From: 10th July 1985 To: 1st August 1985
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: An area approximately 6 cm x 10 cm on the back of each rat was shaved on the day prior to dosing.
- Type of wrap if used: The treatment site was covered with aluminium foil which was held in place by an encircling band of waterproof plaster.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours the plaster and foil were removed, the treated skin washed with soap and water to remove residual test material, rinsed with water and dried.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2100 mg/kg body weight
- Concentration (if solution): The test material was suspended in corn oil at a concentration of 300 mg/ml
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 7 ml/kg
- Concentration (if solution): 300 mg/ml - Duration of exposure:
- 24 h
- Doses:
- 0, 2100 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made for 14 days after treatment. Animals were observed frequently on the days of treatment (Day 1) and decontamination (Day 2), at least once each morning and late afternoon on working days thereafter and at least once each other day. Behaviour, as assessed by changes in general activity including co-ordination and reflexes t aggression r excitability and response to sound, was assessed daily by observing interaction of the rats with the observer and with each other. After plaster removal skin treatment sites were examined daily for evidence of skin irritation.
Body weights were recorded immediately prior bo treatment on Day 1, on Day 8, and immediately prior to necropsy on Day 15.
- Necropsy of survivors performed: yes
Surviving animals were killed by CO2 asphyxiation and subjected to gross post mortem examination for external abnormalities and for abnormalities of the thoracic and abdominal viscera.
- Other examinations performed: clinical signs, body weight - Statistics:
- DATA ANALYSIS: The significance of differences between body weight gains of control and test groups were estimated by the two sample test of Wilcoxon (Wilcoxon, F., Biometrics Bulletin, 1, 80-83, 1945).
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 100 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 100 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured in either male or female rats.
- Clinical signs:
- other: No clinical signs were detected and no deaths occured in either male or female rats dosed with the test item. Administration of 2100 mg/kg body weight to the shaved backs of rats resulted in very slight to slight erythema, dry, flaking skin and very sligh
- Gross pathology:
- One female rat was found to have very slight scabbing and dry skin formation of the treatment site at post mortem examination. No abnormal findings were noted in the other females or in male rats.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not classified
- Conclusions:
- Given data allows the conclusion that the test was well performed and that the results are reliable. It is concluded that the test item is low acute toxicity when administered dermally to male and female Sprague-Dawley rats. The study was performed as a limit test (at least alike). A single dose of 2100 mg/kg was administered, which is above the classification limit according to EU GHS.
- Executive summary:
The purpose of this study was to establish the acute dermal toxicity of the test item in the rat. The test item at a concentration of 300 mg/ml in corn oil was applied at a dose level of 2100 mg/kg body weight for 24 hours under occlusion, to the shaved backs of a group of 5 male and 5 female rats and the animals observed for 14 days after treatment. A group of 5 male and 5 female control rats were similarly treated, except that vehicle only was applied.
No deaths occured during the study.
No clinical signs or adverse effects on body weight were noted during the 14 day observation period. In rats of both sexes the test item caused irritation comprising slight erythema leading to dry, flaking skin and slight to moderate scab formation.
No abnormality was seen at gost mortem examination apart from very slightly dry skin and scabbing of the treatment site in one female.
In both sexes the acute dermal LD50 value was greater than 2100 mg/kg body weight. It is concluded that the test item is of low acute dermal toxicity to male and female Sprague-Dawley rats, no classification acc. EU GHS is triggered.
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