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EC number: 203-109-3 | CAS number: 103-41-3
- 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
The substance is not acute toxic. For oral acute toxicity the LD50 was determined to be 3280 mg/kg bw and for dermal acute toxicity the LD50 > 3000 mg/kg bw.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Groups of test animals (10 per dose group) received the test substance dissolved in corn oil (500 mg/mL) via oral gavage.
Doses ranged from 2.0 to 5.0 g per kg bw. Animals were observed for 14 days post treatment. - GLP compliance:
- no
- Remarks:
- test carried out pre-GLP-guideline
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: 48 hours
- Housing: wire mesh cages in air conditioned room
- Diet: regular diet of Lab Blox; ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Concentration: 500 mg/mL (w/v)
- Doses:
- 2.0, 2.25, 3.0 and 5.0 g/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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption - Statistics:
- Oral LD50 was calculated according to the method of Litchfield, V.T. and Wilcoxon, F., Journal of Pharmacology and Experimetnal Therapeutics, Vol 96, p 99, 1949.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 280 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 620 - <= 4 100
- Mortality:
- 8 animals dosed with 5 g/kg bw died within 24 hours post-dosing, the remaining 2 showed a normal increase in body weight at the end of the 14 days observation period.
- Clinical signs:
- Animals dosed with 5 g/kg bw showed CNS effects 18 hours post-dosing.
Animals dosed at the three lower levels did not show any symptoms prior to death and behaved as normal laboratory animals. - Body weight:
- Normal body weight increase.
All surviving animals ate well. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The oral LD50 was calculated to be 3.28 g/kg bw with 19/20 confidence limit of 2.62 to 4.1 g/kg bw.
- Executive summary:
In the current study the oral LD50 of the test substance was determined in rats in an oral (gavage) acute toxicity test.
No OECD guideline was followed and the study was not GLP.
The rats were fed 2.0, 2.25, 3.0 or 5.0 g/kg bw of the test material dissolved in corn oil, via a rigid stomach tube. 10 animals per dose were used. Following the administration of each dose level the animals were observed for 14 days for signs of toxicity.
8/10 animals dosed with 5 g/kg bw died within 24 hours post-dosing, the remaining 2 showed a normal increase in body weight at the end of the 14 days observation period. All surviving animals ate well and gained body weight in a normal way.
Animals dosed with 5 g/kg bw showed CNS effects 18 hours post-dosing. Animals dosed at the three lower levels did not show any symptoms prior to death and behaved as normal laboratory animals.
The oral LD50 was calculated to be 3.28 g/kg bw with 19/20 confidence limit of 2.62 to 4.1 g/kg bw.
As the LD50 > 2,000 mg/kg bw, the test item is not to be classified as acute toxic according to the CLP regulation.
Reference
Results:
Doses (g/kg bw) |
Response (deaths) |
% observed |
% expected |
Observed minus expected |
(CHI)2 |
2.0 |
2/10 |
20 |
17 |
3 |
.006 |
2.25 |
2/10 |
20 |
23 |
3 |
.005 |
3.0 |
4/10 |
40 |
43 |
3 |
.004 |
5.0 |
8/10 |
80 |
79 |
1 |
.015 |
N1 = 40
ED84 = 5.48
ED50 = 3.28
ED16 = 1.96
S= [(ED84/ED50) + (ED50/ED16)] / 2 = 1.67
fED50 = S2.77 / √ N1= 1.25
ED50 * fED50 = 4.1
ED50 / fED50 = 2.62
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 280 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity
For this endpoint there is 1 study in rats is available.
In this key study the oral LD50 of the test substance was determined in rats in an oral (gavage) acute toxicity test. The rats received doses of 2.0, 2.25, 3.0 or 5.0 g/kg bw of the test material. 8/10 animals dosed with 5 g/kg bw died within 24 hours post-dosing and showed CNS effects 18 hours post-dosing. Animals dosed at the three lower levels did not show any symptoms prior to death and behaved as normal laboratory animals.
The oral LD50 was calculated to be 3.28 g/kg bw with 19/20 confidence limit of 2.62 to 4.1 g/kg bw.
Acute dermal toxicity
For this endpoint there is 1 study available. In this study the acute dermal toxicity of the test substance was tested in rabbits. No guideline was followed and the study was not according to GLP.
The test material was applied once to the clipped backs of the animals and 1, 2 or 3 g/kg bw of the test item were applied under occlusive conditions. The animals were covered with a rubber sleeve and placed in an animal holder for 24 hours. After exposure for 24 hours skin reactions were recorded, the test material was removed and the animals were observed for the following 14 days.
No animals died during the course of the study. The initial moderate erythema on the treated backs was fully reversible after 48 hours. The animals consumed their daily ration, gained weight, behaved normal and showed no toxicity signs. From this it can be concluded that the dermal LD50 > 3000 mg/kg bw.
Justification for classification or non-classification
Acute oral toxicity
According to the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) the substance is not considered to be classified as acute toxic because the LD50 is 3280 mg/kg bw, which is > 2000 mg/kg bw (Table 3.1.1).
Acute dermal toxicity
According to the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) the substance is not considered to be classified as acute toxic because the LD50 is > 3000 mg/kg bw, which is > 2000 mg/kg bw (Table 3.1.1).
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