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Diss Factsheets
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EC number: 947-855-4 | CAS number: -
- 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
No data are available on the skin sensitizing properties of the target substance. This endpoint is filled by read across. In short, for citric acid the available data in public sources have been reviewed. For the ammonium part, a GPMT study is available. It was furthermore considered that ammonium and citric acid are ubiquitous in the human body. Therefore it is scientifically valid to conclude that ammonium dihydrogen citrate in water is not sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See the attached read-across document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: minimal erythema was observed in 2 animals
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: minimal erythema was observed in 1 animal
- Reading:
- other:
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Remarks:
- In accordance with Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- Based on the results of ammonium chloride in a skin sensitisation study with guinea pigs (GPMT), ammonium dihydrogen citrate is considered not to be a skin sensitizer. This result is read across to ammonium dihydrogen citrate.
- Executive summary:
A guinea pig maximisation test was performed, according to EPA guideline and GLP, to assess the skin sensitising potential of ammonium chloride. 30 female guinea pigs, 20 for the test group and 10 for the control group, were used. The study consisted of an induction phase and a challenge phase. In the induction phase intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 5 % (v/v) of the substance was used, whereas in the topical application a concentration of 25% (v/v) was used. In the challenge phase the substance was only applied occlusively on the skin in the left flank at a concentration of 10% (v/v). Results of the challenge phase showed minimal erythema in 2 out of 20 animals in the test group 24 hours after application of the substance. 48 hours after application of the substance, 1 out of 20 animals in the test group showed minimal erythema. No oedema was observed in any of the animals. No clinical abnormalities were observed and bodyweight gain was normal during the study. This result is read across to ammonium dihydrogen citrate.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data are available on the skin sensitizing properties of the target substance. This endpoint is filled by read across. In short, citric acid is used in cosmetic product, with 6795 reported uses at concentrations up to 4% in leave-on formulations, 10% in rinse-off formulations, and 39% in products diluted for (bath) use. In a review by the CIR Expert Panel, several reports are mentioned in which citric acid was shown not to be sensitizing in human volunteers. In combination with its wide dispersive use and the lack of case reports on sensitizing effects, it is concluded that citric acid is not expected to have sensitizing properties. A guinea pig maximisation test was performed, according to EPA guideline and GLP, to assess the skin sensitising potential of ammonium chloride. 30 female guinea pigs, 20 for the test group and 10 for the control group, were used. The study consisted of an induction phase and a challenge phase. In the induction phase intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 5 % (v/v) of the substance was used, whereas in the topical application a concentration of 25% (v/v) was used. In the challenge phase the substance was only applied occlusively on the skin in the left flank at a concentration of 10% (v/v). Results of the challenge phase showed minimal erythema in 2 out of 20 animals in the test group 24 hours after application of the substance. 48 hours after application of the substance, 1 out of 20 animals in the test group showed minimal erythema. No oedema was observed in any of the animals. No clinical abnormalities were observed and bodyweight gain was normal during the study. Based on the results of this study it is concluded that the ammonium part of ammonium dihydrogen citrate is not expected to have skin sensitizing properties.
In this regard, it was furthermore considered that ammonium and citric acid are ubiquitous in the human body. Therefore it is scientifically valid to conclude that ammonium dihydrogen citrate is not sensitizing.
Taken all information together, it is concluded that there are no indications that ammonium dihydrogen citrate has sensitizing properties. Therefore the substance is not classified and further tests are waived.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the current data-set, the substance is not classified as a skin sensitizer according to Regulation (EC) No. 1272/2008 and its amendments.
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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