Registration Dossier
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Diss Factsheets
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EC number: 204-429-6 | CAS number: 120-83-2
- 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 SIDS dossier reports a number of acute oral toxicity studies. The lowest acute oral LD50 reported is 1276 mg/kg bw. This value is taken as the oral toxicity end point as it was the lowest and so most conservative value.
In addition an acute dermal study is reported and referenced herein since it relates to skin corrosivity. The LD50 is reported to be 780 mg/kg/bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 276 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 780 mg/kg bw
Additional information
Annex VII of Regulation (EC) No 1907/2006 in section 8.5 states the study/ies do(es) not generally need to be conducted if the substance is classified as corrosive to the skin. This is reiterated in section R.7.4.2 of the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7a : Endpoint specific guidance.
Therefore, this endpoint is not required for a substance classified as corrosive to skin. However, since a number of LD50 acute oral toxicity studies are publicly available they have been reported here. The lowest credible acute oral LD50 reported was 1276 mg/kg bw, attracting a DSD classification of 'Harmful if swallowed' (R22) and a CLP classification of 'Acute toxicity 4' (H302) .
The endpoints presented are summarised in the table below:-
LD50 mg/kg | IUCLID Endpoint |
1276 | 001 |
2830 | 002 |
580 | 003 |
1630 | 004 |
3670 (Males) | 005 |
4500 (Females) | 005 |
1630 (Males and Females) | 006 |
>2400 - <2800 (Females) | WIL-22001 |
In addition, an acute dermal study is reported in the SIDS dossier. The requirement to perform an acute dermal toxicity study is listed in Annex VIII of Regulation (EC) No 1907/2006. Therefore it is not required. However, given that the most likely route of any exposure to this substance would be through skin contact in either manufacture or use it is prudent to include this study reference. The SIDS dossier assigns a validity of 1 (valid without restrictions) to this study which was conducted according to OECD guideline 402. The study was performed with the substance in molten form in order to bear closest resemblance to any potential human exposure by accidental spillage. In male rats the minimum lethal dose was 300 mg/kg/bw. 4/5 deaths were observed at the high dose level of 2000 mg/kg in males and females. A slight decrease in motor activity was noted from 200 mg/kg which was no longer present 24 hours after application. However as the dose increased (300 mg/kg to 1400 mg/kg) a marked decrease in motor activity was observed and respiratory impairment was noted. These signs were still present up to 6 and 9 days respectively after treatment. At 2000 mg/kg, coma, soft faeces and blood-like colouration in urine were observed. Locally, at all doses, marked to severe irritation resulting in skin necrosis was noted after removal of the patch, which was hardly reversible within 2 weeks.
Justification for classification or non-classification
The substance is classified as in Annex I to 67/548/EEC as :-
Toxic, T, R24 - Toxic in contact with skin, R22 - Harmful if swallowed, R34
and in Annex VI (Table 3.1) of CLP-Regulation (EC no 1272/2008 as :-
Acute Toxicity 4, H302 - Harmful if swallowed
Acute Toxicity 3 H311 - Toxic in contact with skin
Skin Corr IB H314 - Causes severe skin burns and eye damage
Analysis of data summarised here supports this classification.
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.