Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 916-868-7 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study in rats according to OECD Guideline 401 (BASF SE, 1989), a discriminating dose of > 5000 mg/kg bw was determined.
In a pre-GLP oral toxicity study in rats comparable to OECD Guideline 401 (BASF SE, 1977), a LD50 of 4722 mg/kg bw was determined.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-04-01 to 1989-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1984-09
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: 216096.89
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 20 °C in the dark
- Stability of the test substance in the vehicle: At least 48 hours in carboxymethylcellulose
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The formulations were prepared immediately prior to dosing. The test article was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test article in vehicle was obtained by a homogeniser, Concentration of test article in vehicle was varied to allow constant dosage volume in terms of ml/kg body weight.
OTHER SPECIFICS: Orange, solid - Species:
- rat
- Strain:
- Wistar
- Remarks:
- outbred, SPF-Quality
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: ~ 8 weeks
- Weight at study initiation: ♂: 267 - 305 g; ♀: 177 - 200 g
- Fasting period before study: Food was withheld overnight prior to dosing until ~ 3 - 4 hours after administration of the test article.
- Housing: Housed in groups of five per sex in polycarbonate cages.
- Diet: standard pelleted laboratory animal diet (RMH-B from Hope Farms, Woerden, The Netherlands), ad libitum
- Water. tap-water, ad libitum
- Acclimation period: Five days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test article was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observation at periodic intervals on the day of dosing (day 1) and twice daily thereafter for at least 14 days. Body weights at test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes, all animals were necropsied and descriptions of all macroscopic abnormalities were recorded. All animals surviving to the end of the observation period were sacrificed by carbon dioxide asphyxiation and subjected to necropsy.
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Diarrhoea was noted in all animals on the day of treatment during the final observation (4.15 hours after dosing). No other clinical signs of toxicity or behavioural changes were seen over the 15 day observation period.
- Gross pathology:
- Macroscopic examination of all animals at termination did not reveal any abnormalities.
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- GLP compliance:
- not specified
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: ENR 41 - Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 160 - 180 g
- Fasting period before study: overnight before administration
- Housing: in groups of 5 in Macrolon cages (type 3).
- Diet: ad libitum, rat food - NAFAG, Gossau SG, Switzerland
- Water: ad libitum (not specified)
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5 - Route of administration:
- oral: unspecified
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10, 20, or 30 % - Doses:
- 1000, 2150, 3590, 4640, and 6000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times within the first hours after administration, thereafter at least once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- LD 50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404 - 408).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 722 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 770 - < 5 916
- Mortality:
- see Table 1
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. The surviving animals recovered within 12 to 14 days.
- Gross pathology:
- No substance related gross organ changes were seen.
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Table 1: Rates of death
Dose mg/kg bw |
Conc. % of Formulation |
No of animals |
Died within |
||||||||||
1 h |
24 h |
48 h |
7 d |
14 d |
|||||||||
|
|
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
1000 |
10 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2150 |
20 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
3590 |
30 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
4640 |
30 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
4 |
6000 |
30 |
5 |
5 |
0 |
0 |
1 |
0 |
1 |
0 |
4 |
2 |
5 |
3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Klimisch code 2
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study according to OECD Guideline 401 (BASF SE, 1989), the test substance was administered to wistar rats of both sexes (5 each) by oral gavage at a limit dose of 5000 mg/kg body weight, followed by a 15 day observation period. No mortality occurred during the study period. Diarrhoea was noted in all animals on the day of treatment during the final observation. All animals showed body weight gain during the study period. Macroscopic examination of all animals at termination did not reveal any abnormalities. The oral discriminating dose of the test substance in rats of both sexes, was estimated to be > 5000 mg/kg body weight.
This finding is supported by a pre-GLP acute oral toxicity study comparable to OECD Guideline 401 in Tif: RAIf (SPF) rats (BASF SE, 1977). In this study, a LD50 of 4722 mg/kg bw was determined.
It is noteworthy that the percentage shares of components in the composition of the test substance changed between the two studies. However, these changes did not lead to substantial changes in the acute toxic potential of the test substance.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
A discriminating dose for acute oral (> 5000 mg/kg bw) toxicity was determined. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.