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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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Oral, rat (OECD 414, GLP): NOAEL (maternal) = 3 mg/kg bw/d, NOAEL (developmental toxicity) ≥ 20 mg/kg bw/d
RA from source substance bis(hydroxyammonium) sulfate (CAS 10039-54-0)
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- 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
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no treatment-related adverse effects on dams observed
- Remarks on result:
- other: Source: 7.8.2-1
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- organ weights and organ / body weight ratios
- Remarks on result:
- other: Source: 7.8.2-1
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- haematology
- organ weights and organ / body weight ratios
- Remarks on result:
- other: Source: 7.8.2-2
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- gross pathology
- haematology
- organ weights and organ / body weight ratios
- Remarks on result:
- other: Source: 7.8.2-2
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Effect level:
- > 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects on the fetuses occured at the highest tested dose level of 20 mg/kg bw.
- Remarks on result:
- other: Source: 7.8.2-1
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Based on the analogue approach, no adverse effects on developmental toxicity are considered for hydroxylammonium chloride. The NOAEL systemic was considered to be 3 mg/kg bw/day in dams and the NOAEL for developmental toxicity was considered to be > 50 mg/kg bw/day in the offspring.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate, reliable and consistent studies, 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-IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no data regarding reproductive toxicity available for hydroxylammonium chloride (CAS 5470-11-1). In order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.7, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. 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).
As no data is available regarding reproductive toxicity for hydroxylammonium chloride (CAS 5470-11-1) information from the analogue substance bis(hydroxylammonium)sulfate (CAS 10039-54-0) are taken into account to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.7.
CAS 10039-54-0
A pre-screen test on developmental toxicity of bis(hydroxylammonium)sulfate (CAS 10039-54-0) was investigated according to OECD Guideline 414 (prenatal developmental toxicity study) and GLP (reference 7.8.2-2). Groups of 10 presumed pregnant female Wistar rats received daily oral gavage doses of the test substance at 5, 15 and 30 mg / kg bw/day during gestational days 6 to 15. Control animals were treated with the concurrent vehicle. On day 16 of gestation the animals were euthanized and examined for maternal and fetal parameters. Maternal toxicity such as severe haemolytic anemia, significant increase of absolute and relative spleen weights and a considerable enlargement of the spleen were observed in mid- and high-dose females. Based on these results in maternal animals the NOAEL for maternal toxicity was found to be 5 mg/kg bw/day. Examination of fetus litter size and weights, offspring viability (number alive and number dead) and grossly visible abnormalities revealed no differences to controls and thus no indication for effects on developmental toxicity. A NOAEL for developmental toxicity was not derived, since the examination of the uterus content was very limited due to the stage of development of the implants on the day when the study was terminated (Day 16 p.c.).
Based on the results of the pre-screen test, a second developmental toxicity test with bis(hydroxylammonium)sulfate (CAS 10039-54-0) was investigated according to OECD Guideline 414 (prenatal developmental toxicity study) and under GLP conditions (reference 7.8.2-1). Untreated male Wistar rats were mated with untreated female Wistar rats, which then received daily oral gavage doses of the test substance at concentrations of 1, 3, 10 and 20 mg/kg bw/day during gestational days 6 to 15. 25 females per treatment group were used. Control animals received the vehicle Milli-Q-water. On day 20 post coitum the animals were sacrificed and examined for maternal and fetal parameters. The test substance caused some overt signs of maternal toxicity at 10 and 20 mg/kg bw/d, while 1 or 3 mg/kg bw/d were tolerated by the dams without any substance-induced findings. At the dose levels of 10 and 20 mg/kg bw/d a significant enlargement of the spleen was observed, which was a consequence of a severe haemolytic anemic process already demonstrated in the pre-screen test on developmental toxicity (reference 7.8.2-2). The gestational parameters were not influenced by the test substance. Based on the number of implantations, number of total litter losses by resorption, mortality, clinical signs, body weight, gross pathology and organ weights of maternal animals the NOAEL for maternal toxicity was found to be 3 mg/kg bw/day. Examination of fetus litter size and weights, offspring viability (number alive and number dead), sex ratio, grossly visible abnormalities, external, soft tissue and skeletal abnormalities revealed no adverse effects in any treatment groups compared with the control animals. The NOAEL for developmental toxicity in rats for bis(hydroxylammonium)sulfate (CAS 10039-54-0) was found to be ≥ 20 mg/kg bw/day.
Conclusion for developmental toxicity
The available data show that the analogue substance bis(hydroxylammonium)sulfate (CAS 10039-54-0) does not show intrinsic hazardous properties with regard to developmental toxicity. Therefore, based on common functional groups and structural similarities, hydroxylammonium chloride (CAS 5470-11-1) is not expected to exhibit developmental toxicity/teratogenicity.
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.
The available data on developmental toxicity from the source substance bis(hydroxylammonium)sulfate (CAS 10039-54-0) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.
Therefore, applying the RA-A approach, the target substance is also considered not to meet the classification criteria for developmental toxicity according to Regulation (EC) No 1272/2008
Additional information
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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