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EC number: 226-798-2 | CAS number: 5470-11-1
- 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 toxicity, oral (similar to OECD 401, RL2), male and female rats: LD50 = 642 mg/kg bw
RA from source substance bis(hydroxyammonium) sulfate (CAS 10039-54-0)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 642 mg/kg bw
- Interpretation of results:
- other: Category 4 based on CLP/EU GHS criteria, according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Acute Oral 4, H302 (Annex VI harmonized classification)
The available data on acute toxicity (oral) are in consistency with the harmonized classification according to Regulation (EC) 1272/2008, Annex VI.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 642 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (RL2) from a reference substance with similar structure. Read-across is justified based on structural similarities and similar chemical behaviour. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Meets generally accepted scientific principles. But route of application (subcutaneous) is not in line with international guidelines and therefore not acceptable for the assessment of acute dermal toxicity. The present study may only be used as worst case assessment and support for the waiving argumentation.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Test item was applied subcutaneously
- Parameters analysed / observed: LD 50 - GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- mouse
- Strain:
- other: Agnes-Blum
- Sex:
- female
- Type of coverage:
- other: subcutaneous application
- Vehicle:
- not specified
- Duration of exposure:
- 24 h
- Doses:
- 3 different doses
- No. of animals per sex per dose:
- 10 females
- Control animals:
- not specified
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 125.08 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: effect level calculated from 1.8 mMol/kg bw
- Interpretation of results:
- other: Category 4 based on CLP/EU GHS criteria, according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Acute Dermal 4, H312 (Annex VI harmonized classification)
The subcutaneous application of the test substance can be considered as worst case demonstrating the hazardous potential of hydroxylammonium chloride which is in line with the harmonized classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- In accordance with Column 2 of Annex VIII, Section 8.5, of Regulation (EC) No 1907/2006, in addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. Since inhalation of the substance is unlikely with regard to the particle size, testing by the dermal route is appropriate.
Supporting information comprises a study with the target substance using subcutaneous application of the test substance, which can be considered as worst case demonstrating the hazardous potential of hydroxyl ammonium chloride which is in line with the harmonized classification as Acute Tox 4 dermal, H312 according to Annex VI of the CLP Regulation (EC) 1272/2008.
Additional information
Justification for read-across
No data on acute toxicity after oral administration are available for the target substance hydroxylammonium chloride (CAS 5470-11-1). Therefore, read across from the relevant source substance bis(hydroxyammonium) sulfate (CAS 10039-54-0) was applied to obtain information regarding acute toxicity after oral exposure.
Read-across from an appropriate reference substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.5. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
There is supporting data available regarding acute dermal toxicity for Hydroxylammonium chloride (CAS 5470-11-1).
Acute oral toxicity
CAS 10039-54-0
An acute oral toxicity study was performed with the test substance similar to OECD guideline 401 (reference 7.2.1-1). Groups of 10 male and 10 female rats received oral gavage doses of 200 - 1600 mg/kg bw. The animals were observed for 7 days after administration. The following mortalities were recorded: 0/20, 1/20, 6/20, 13/20, 10/20, 15/20, 18/20 and 20/20 at 200, 400, 500, 640, 800, 1000, 1250 and 1600 mg/kg bw, respectively. Clinical signs comprised intermittent breath and dyspnoe, apathy, cynosis, agitated behaviour, stretching, and slight tremor at a dose range of 400 – 800 mg/kg bw immediately after application of the test substance. Some of the surviving animals had unkempt fur and intermittent breath on the next day. Similar effects were seen at a dose range of 1000 – 1600 mg/kg bw shortly after application of the test substance, some of which persisted until the next day. Necropsy revealed a dark blue to violet or black discolouration and enlargement of the spleen. The rest of the animals showed no abnormal gross findings in the examined organs and tissues. The acute oral LD50 was 642 mg/kg bw.
The analogue substance Bis (hydroxyammonium) sulfate (CAS 10039-54-0) meets the criteria for classification as Acute Tox. 4, H302, according to Regulation (EC) 1272/2008 based on the reported findings on acute oral toxicity.
Acute dermal toxicity
CAS 5470-11-1
Supporting information is available on an acute dermal toxicity study performed with the test substance (Oehme et al., 1968). 10 female Agnes-Blum mice were injected with three different doses of the test substance for 24 h. No further information is available. The acute dermal LD50 in mice was found to be 125.08 mg/kg bw after subcutaneous application.
The subcutaneous application of the test substance can be considered as worst case demonstrating the hazardous potential of hydroxyl ammonium chloride which is in line with the harmonized classification as Acute Tox 4 dermal, H312 according to Annex VI of the CLP Regulation (EC) 1272/2008.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Hydroxylammonium chloride, data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Applying the RA-A approach and in consistency with the harmonized classification, which is available for the target and the source substance bis(hydroxyammonium) sulfate (CAS 10039-54-0) according to Regulation (EC) 1272/2008, Annex VI (both with the Index No. 612-123-00-2), the target substance Hydroxylammonium chloride meets the criteria for classification as Acute oral Tox. Cat. 4, H302 and Acute dermal Tox. Cat. 4, H312.
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.
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