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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-183-7 | CAS number: 104-19-8
- 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
Acute oral toxicity: In an acute oral toxicity in Wistar (SPF) rats, following the acute toxic class method in accordance with the OECD guideline 423, the LD50 was determined to be in the range 200-2000 mg/kg for both females and males (K1, Huygevoort A, 2002).
Acute dermal toxicity: in an acute dermal toxicity study in Albino rabbits, the LD50 was determined to be 0.51mL/kg. The test substance is classified as acute dermal toxicant category 4. As the substance is corrosive to skin, no additional acute toxicity testing is required.
Acute inhalation toxicity: An acute inhalation toxicity study does not need to be performed as the substance is corrosive to the skin.
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:
- From 2002-01-03 to 2002-01-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 180601
- Expiration date of the lot/batch: 2002-10-25
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no details provided
- Route of administration:
- oral: gavage
- Details on oral exposure:
- no details provided
- Doses:
- 200 mg/kg ; 2000 mg/kg body weight
- No. of animals per sex per dose:
- 2 groups:
2 females - 2000 mg/kg body weight
2 females - 200 mg/kg body weight - Control animals:
- no
- Details on study design:
- Animals were subjected to daily observations and weekly determination of body weight.
All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 200 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two females were found dead within 5.5 hours post-treatment (2000 mg/kg). No further mortality occured.
- Clinical signs:
- other: One decedent showed lethargy, hunched posture, uncoordinated movements, slow breathing, piloerection and ptosis. No clinical signs of toxicity were noted in the other decedent. Animals given 200 mg/kg showed lethargy on day 1.
- Gross pathology:
- Dark red discoloration of the glandular mucosa of the stomach and dark red discoloration of the forestomach was noted in one animals that died during the study, at macroscopic post mortem examination. The other decedent showed dark red discoloration of the forestomach and the jejunum and ileum contained hemorrhagic fluid. Macroscopic post mortem examination of the other animals did not reveal any abnormalities.
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The oral LD50 value for female rats was established to be within the range of 200-2000 mg/kg body weight.
Based on these rsults and according to the CLP Regulation, the test substance is considered classified as acute oral toxicant category 3.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- other:
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was performed according to accepted scientific methods.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Sex:
- male
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- The product as receive was held in continuous 24-hour contact with the shaved skin
- Duration of exposure:
- 24 hrs
- Doses:
- 0.313, 0.625, 1.25 mL/kg
- No. of animals per sex per dose:
- No data
- Control animals:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 0.51 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.39 - <= 0.67
- Mortality:
- 1.25 mL/kg: 5/5 animals died within 6-24 hrs
0.625 mL/kg: 4/5 animals died (3 animals on day 3, 1 animals on day 5)
0.313 mL/kg: 0/5 animals died - Clinical signs:
- other: signs of intoxication observed: depression
- Gross pathology:
- Gross pathology of surviving animals was performed, and no abnormalities were observed.
- Other findings:
- signs of irritation observed: eschar formation
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- An LD50 value of 0.51 mL/kg was established. The test substance is considered classified as acute dermal toxicant category 4 according to CLP Regulation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Quality of whole database:
- LD50 was established at 0.51mL/kg.
Additional information
Acute oral toxicity:
The study aimed to assess the acute oral toxicity of the test substance to the rat using the acute toxic class method in male and female Wistar (SPF) rats, according to the OECD guideline 423 (K1, Huygevoort A, 2002).
Initially, one group of Wistar rats, consisting of two females, received a single oral dose of 2000 mg/kg body weight (dose volume 2.27 ml/kg). Due to mortality, one additional group of two females was dosed at 200 mg/kg (dose volume 0.23 ml/kg). Animals were subjected to daily observations and weekly determination of body weight. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
Two females were found dead within 5.5 hours post treatment (at 2000 mg/kg). No further mortality occurred. One decedent showed lethargy, hunched posture, uncoordinated movements, slow breathing, piloerection and ptosis. No clinical signs of toxicity were noted in the other decedent. Animals given 200 mg/kg showed lethargy on day 1. Body weight gain of the animals during the 8 -day study period was considered to be normal. Dark red discolouration of the glandular mucosa of the stomach and dark red discolouration of the forestomach was noted in one animals that died during the study, at macroscopic post mortem examination. The other decedent showed dark red discolouration of the forestomach and the jejunum and ileum contained hemorrhagic fluid. Macroscopic post mortem examination of the other animals did not reveal any abnormalities. The oral LD50 value for female rats was established to be within the range of 200-2000 mg/kg.
Acute dermal toxicity:
In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). As this substance is classified as corrosive to skin (Cat 1A), the dermal route of exposure can be waived.
A K2, supporting study is available (1966). In this study, LD50 is calculated at 0.51mL/kg in male albino rabbits.
Acute inhalation toxicity:
In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). As this substance is classified as corrosive to skin (Cat 1A), the inhalation route of exposure can be waived.
Justification for classification or non-classification
The substance is classified as Acute oral toxicant Category 3 and acute dermal toxicant category 4 according to EU CLP Regulation.
No acute inhalation toxicity testing is performed, as the substance is classified as corrosive to skin according to EU CLP.
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.