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EC number: 604-012-2 | CAS number: 137296-15-2
- 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
No data is available for ammonium-S-lactate itself. Therefore, available data from repeated dose toxicity studies conducted with suitable read-across partners were used in a weight-of-evidence approach to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for ammonium-S-lactate.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Regarding general conditions, no obvious findings were observed in any group.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was found in any groups throughout the treatment period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No test-substance related change in the body weights was found.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No test-substance related change in food intake was found, except for a tendency for increase of food intake in the male 3.0% group. The actual daily intakes of the test substance showed a good correlation with the expected dose.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No significant variation was found in erythrocytic parameters and Plt among the groups- Some slight changes were found in WBC parameters but therre was no dose-relation and these were therefore considered to be incidental.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No dose-related alteration was found in any of the serum biochemical parameters.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Absolute and relative kidney weights were increased or showed a tendency for increase at 3.0% in both sexes. Absolute spleen weights were decreased and relative liver weights were increased in the 3.0% male dose group. No dose-related changes were found in the other organs.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no obvious macroscopic finding in any dose group.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Histopathologically, several non-neoplastic lesions, such as bile duct proliferation in the liver and focal myocarditis in the heart were noted in the control and 3.0% group.
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- As neoplastic lesions, malignant pheochromocytoma of the adrenal in the male 3.0% group, two adenomas in the anterior pituitary in females of the 3.0% group and uterine endometorial stromal polyp in a female control was noted.
- Other effects:
- not examined
- Dose descriptor:
- NOAEL
- Effect level:
- 0.6 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects in the mid-dose
- Dose descriptor:
- LOAEL
- Effect level:
- 3 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 3 other: %
- System:
- other: organ weight
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Conclusions:
- In conclusion, based on the results obtained from a 52-week chronic feeding study in male and female Fisher rats with ammonium sulphate at dietary concentrations of 0, 0.1, 0.6 and 3.0%, the oral NOAEL is considered to be 0.6%, which is equivalent to 256 and 284 mg/kg bw/day in male and female rats.
- Executive summary:
In a 52-week chronic feeding study in male and female Fisher 344/DuCrj rats (10/sex/dose group), ammonium sulphate was applied at concentrations of 0, 0.1, 0.6 and 3.0 % via the diet. Absolute and relative kidney weights were increased or showed a tendency for increase at 3.0 % in both sexes. Absolute spleen weights were decreased and relative liver weights were increased in the 3.0 % male dose group. No dose-related changes were found in other organs investigated. Moreover, no effects were found on mortality, body weight, hematological and serum biochemical parameters. Effects were neither seen in gross and histopathological examinations. Based on the results of this study, the oral NOAEL is considered to be 0.6 %, which is equivalent to 256 and 284 mg/kg bw/day in male and female rats.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 415 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Comparable to guideline study
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Remarks on result:
- other: no adverse systemic effects observed
- Critical effects observed:
- no
- Conclusions:
- In a 90-day dermal study, 1 mL/kg bw/d of a 12 % ammonium lactate lotion, pH 5.0–5.5, was applied to the backs of six rabbits, three per sex, and 4 mL/kg bw/d were applied to the backs of eight rabbits, four per sex. Saline was applied to the backs of a control group of 10 rabbits, five per sex. Use of restraints was not specified. The backs of half of the animals were abraded.
Three control, one low-dose, and two high-dose animals, which died on study due to acute pneumonia and/or mucoid enteritis, were replaced. Feed consumption, body weights, haematology, clinical chemistry, and urinalysis were normal for all test groups. Absolute kidney weights of the low-dose group were significantly increased compared to controls, while the relative kidney weights were comparable. Both dose groups had mild irritation, described as a minimal to slight acanthosis, inflammatory cellular infiltration, and hyperkeratosis. Three of the high-dose animals developed minimal focal ulceration of the application areas. - Executive summary:
In a 90-day dermal study, 1 mL/kg bw/d of a 12 % ammonium lactate lotion, pH 5.0–5.5, was applied to the backs of six rabbits, three per sex, and 4 mL/kg bw/d were applied to the backs of eight rabbits, four per sex. Saline was applied to the backs of a control group of 10 rabbits, five per sex. Use of restraints was not specified. The backs of half of the animals were abraded.
Three control, one low-dose, and two high-dose animals, which died on study due to acute pneumonia and/or mucoid enteritis, were replaced. Feed consumption, body weights, haematology, clinical chemistry, and urinalysis were normal for all test groups. Absolute kidney weights of the low-dose group were significantly increased compared to controls, while the relative kidney weights were comparable. Both dose groups had mild irritation, described as a minimal to slight acanthosis, inflammatory cellular infiltration, and hyperkeratosis. Three of the high-dose animals developed minimal focal ulceration of the application areas.
Reference
Three control, one low-dose, and two high-dose animals, which died on study due to acute pneumonia and/or mucoid enteritis, were replaced. Feed consumption, body weights, hematology, clinical chemistry, and urinalysis were normal for all test groups. Absolute kidney weights of the low-dose group were significantly increased compared to controls, while the relative kidney weights were comparable. Both dose groups had mild irritation, described as a minimal to slight acanthosis, inflammatory cellular infiltration, and hyperkeratosis. Three of the high-dose animals developed minimal focal ulceration of the application areas.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available for ammonium-S-lactate itself. Therefore, available data from repeated dose toxicity studies conducted with suitable read-across partners (ammonium sulphate, ammonium chloride and calcium lactate) were used in a weight-of-evidence approach to assess the specific target organ toxicity of the target substance. As the target substance dissociates into ammonium and lactate ions in aqueous media, the assessment of the repeated dose toxicity potential can be based on available data of dissociable ammonium compounds and lactic acid. Lactic acid is a ubiquitous and integral element of mammalian metabolism and therefore of minor toxicological relevance in comparison to ammonium which is considered to be toxicologically more relevant than lactic acid. Further details on the read-across rationale are provided in IUCLID section 13.
In a 13-week subchronic oral toxicity study conducted similar to OECD 408, calcium lactate in drinking water was administered to Fischer 344/DuCrj rats. In this study, 5% calcium lactate in drinking water or diet does not result in adverse effects.
The repeated dose toxicity of ammonium chloride was examined in 28- and 90-day oral feeding studies. In the 28-day repeated dose toxicity the NOAEL was determined to be 2214.5 mg/kg bw/day for both sexes (corresponding to 4434 mg/kg bw/day ammonium-S-lactate). In the higher dose an effect on body weight and body weight gain was noted. In a 90-day repeated dose toxicity study the NOAEL was determined to be 1695.7 mg/kg bw/day for both sexes (corresponding to 3395 mg/kg bw/day ammonium-S-lactate). Further results were derived from a repeated dose toxicity study, in which ammonium chloride was administered to 10 male Sprague-Dawley rats/dose via the diet at a dose level of 12300 ppm for 70 days. Based on the results, the NOAEL was determined to be 12300 ppm (equivalent to 684 mg/kg bw/day; recalculated to 1369 mg/kg bw/day ammonium-S-lactate)
The repeated dose toxicity of ammonium sulphate was examined in a 52-week oral feeding study. In this chronic study, the NOAEL was determined to be 256 mg/kg bw/day for male rats and 284 mg/kg bw/day for female rats (corresponding to 415 and 461 mg/kg bw/day ammonium-S-lactate). In the high dose group, absolute and relative kidney weights were increased or showed a tendency for increase in both sexes. Absolute spleen weights were decreased, and relative liver weights were increased in male dose group. Moreover, supporting data is available from the review article by Anderson (1998). In this peer-reviewed publication, lactic acid and ammonium-DL-lactate were applied to the skin of rats or rabbits. No major systemic effects were noted. As the information provided was very limited, the data are not considered for assessing the repeated dose toxicity study of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for the target substance ammonium-S-lactate.
Justification for classification or non-classification
Based on the available data from the read-across partners, the target substance ammonium-S-lactate does not warrant classification for specific target organ toxicity in accordance with CLP Regulation 1272/2008.
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