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EC number: 284-943-5 | CAS number: 84989-53-7
- 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:
- 2017-05-03 to 2017-05-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- EC Number:
- 284-943-5
- EC Name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- Cas Number:
- 84989-53-7
- Molecular formula:
- C42H44CoN12.Cl
- IUPAC Name:
- hydroxylamine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube in the morning. The test item (at concentration of 0.2 mg/mL) was administered at a dose volume of 10 mL/kg body weight.
- Doses:
- - step 1 and 2: 2000 mg/kg body weight
- No. of animals per sex per dose:
- - steps 1 and 2: 3 females each dose
- Control animals:
- no
- Details on study design:
- Preparation of the Animals
The animals were marked for individual identification by tail painting. Prior to the administration a detailed clinical observation was made of all animals. Only healthy animals were used.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
Observation Period
The surviving animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
Weight Assessment
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
Evaluation of Results
Results were interpreted according to OECD Guideline 423, Annex 2 and GHS. Individual reactions of each animal were recorded at each time of observation. Toxic response data were recorded by dose level. Nature, severity and duration of clinical observations were described. The body weight changes were summarised in a tabular form. Necropsy findings were described. - Statistics:
- n.a.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item showed no mortality but acute oral toxicity characteristics after a single dose administration.
- Clinical signs:
- At a concentration of 2000 mg/kg all animals showed moderate toxic effects which recovered within 2 days post-dose.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced and increased spontaneous activity, piloerection, half eyelid closure, hunched posture, slow movements and prone position. - Body weight:
- None of the animals showed weight loss during the observation period.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
LD50 Cut-Off
Starting Dose (mg/kg bw) | Number of animals | Number of intercurrent deaths | LD50 Cut-Off (mg/kg bw) |
2000 | 6 | 0 | > 2000 |
bw = body weight
Absolute Body Weights in g and Body Weight Gain in %
Step/ |
Animal no. / sex
|
Days after dosing
|
Body weight change in comparison to day 1 (%)
|
||
1 |
8 |
15 |
15 |
||
Step 1 / |
1 /female |
161 |
191 |
203 |
26 |
2 /female |
158 |
177 |
195 |
23 |
|
3 /female |
158 |
178 |
184 |
16 |
|
Step 2 / 2000 |
4 /female |
170 |
188 |
193 |
14 |
5 /female |
188 |
216 |
217 |
15 |
|
6 /female |
167 |
181 |
196 |
17 |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Not classified according to CLP
- Conclusions:
- A single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality.The median lethal dose of the test substance, after a single oral administration to female rats, observed over a period of 14 days, is: LD50cut-off (rat): > 2000 mg/ kg bw.
- Executive summary:
The purpose of this study was to assess the toxicity of the test article when administered to rats after a single oral dose. The study was carried out in accordance with OECD TG 423 and in compliance to GLP.
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at the test facility were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study showing signs of toxicity. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced and increased spontaneous activity, piloerection, half eyelid closure, hunched posture, slow movements and prone position. All symptoms recovered within 2 days post-dose. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but no mortality. The median lethal dose after a single oral administration to female rats, observed over a period of 14 days is: LD50cut-off (rat): > 2000 mg/ kg bw.
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