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EC number: 632-556-0 | CAS number: 304859-44-7
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 September 2012 to 11 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction product of salicylaldehyde and formaldehyde and phenol
- EC Number:
- 632-556-0
- Cas Number:
- 304859-44-7
- Molecular formula:
- C6H5O(C13H10O2)m(C7H6O)nH values on m and n are variable as this is a UVCB substance
- IUPAC Name:
- Reaction product of salicylaldehyde and formaldehyde and phenol
- Test material form:
- solid
- Details on test material:
- - Description: Light red / solid
- Storage conditions: Room temperature (15-30 °C), protected from humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ~11 weeks old
- Weight at study initiation: 204 - 236 g
- Fasting period before study: On the day before treatment, the animals were fasted. The food but not water was withheld during an overnight period. The food was returned 3 hours after the treatment.
- Housing: 3 animals / group in Type II polypropylene/polycarbonate cages with Lignocel Bedding. Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Diet: ad libitum. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Water: ad libitum tap water from the municipal supply
- Acclimation period: 19, 20 or 21 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 15 - 20 air exchanges/hour
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: test material was freshly formulated at a concentration of 200 and 30 mg/mL in the vehicle, in the Central Dispensary Unit of CiToxLAB Hungary Ltd. on the day of administration.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test material was milled before it was formulated. The formulation container was stirred continuously during administration with the objective of ensuring that the syringe was filled from a suspension.
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level was 2000 mg/kg bw. Due to mortality, Groups 2 and 3 received a dose level of 300 mg/kg bw, respectively. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females at 2000 mg/kg bw and 6 females at 300 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on Group 1 at 10 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter and on the surviving animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly after. Moreover, the body weight of found dead animals was recorded at necropsy.
- Necropsy of survivors performed: yes, macroscopic examination was performed on all animals. The surviving animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthasol® 40 %). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Statistics:
- The method used was not intended to allow the calculation of a precise LD50 value.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - The test material caused mortality at the dose level of 2000 mg/kg bw (2/3) and at the dose level of 300 mg/kg bw (2/6).
- Clinical signs:
- other: - Treatment with the test material at the dose level of 2000 mg/kg bw caused decreased activity (3/3), hunched back (2/3), prone position (1/3), piloerection (2/3), cold to touch (1/3), incordination (3/3), increased salivation (1/3), faeces liquid (1/3),
- Gross pathology:
- - In the Dose group 2000 mg/kg bw, in the female 6291, beige coloured, creamy material found in the digestive content of the stomach and duodenum was regarded as potentially related to the administration of the test material. In the females 6291 and 6293, red discoloration of the non-collapsed lungs were noted at necropsy.
- In the 300 mg/kg bw Dose group, in the female 6295, red discolouration of the non-collapsed lungs considered to be typical for found dead. In the female 6311, beige coloured creamy material found in the digestive content of the stomach and duodenum was regarded as potentially related to the administration of the test material. Red discolouration of the non-collapsed lungs were also noted in this animal at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU criteria: category 4, H302: harmful if swallowed
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test material was found to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats.
- Executive summary:
The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423 and EU Method B.1. Tris, under GLP conditions. The single-dose oral toxicity testing was performed using the acute toxic class method.
The test material was administered in dimethyl sulfoxide (DMSO) at concentrations of 200 and 30 mg/mL with a dosing volume of 10 mL/kg bw. Initially, three female female rats (Group 1) were treated at a dose level of 2000 mg/kg bw. The test material caused mortality in this group (2/3). Therefore a second group (Group 2) was treated at a dose level of 300 mg/kg bw. The test material caused mortality in this group (1/3). A confirmatory group (Group 3) was treated at the same dose level. One of three rats died at this dose group (Group 3), therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. Clinical observations were performed on Group 1 at 10 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter and on the surviving animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
The test material caused mortality at the dose level of 2000 mg/kg bw (2/3) and at the dose level of 300 mg/kg bw (2/6). Treatment with the test material at the dose level of 2000 mg/kg bw caused decreased activity (3/3), hunched back (2/3), prone position (1/3), piloerection (2/3), cold to touch (1/3), incoordination (3/3), increased salivation (1/3), faeces liquid (1/3), and death (2/3). Treatment with the test material at dose level 300 mg/kg bw caused decreased activity (6/6), hunched back (6/6), piloerection (1/6), faeces liquid (4/6), prone position (1/6) and death (2/6). Body weight gains of test material treated animals during the study showed no indication of a treatment-related effect at the dose level of 300 mg/kg bw.
In the Dose group 2000 mg/kg bw, in the female 6291, beige coloured, creamy material found in the digestive content of the stomach and duodenum was regarded as potentially related to the administration of the test material. In the females 6291 and 6293, red discolouration of the non-collapsed lungs were noted at necropsy. In the 300 mg/kg bw Dose group, in the female 6295, red discolouration of the non-collapsed lungs considered to be typical for found dead. In the female 6311, beige coloured creamy material found in the digestive content of the stomach and duodenum was regarded as potentially related to the administration of the test material. Red discolouration of the non-collapsed lungs was also noted in this animal at necropsy.
Under the conditions of this study, the acute oral LD50 value of the test material was found to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats.
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