Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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 read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- ca. 28.8 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- element
- Remarks:
- NH3-N
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CI = 9.92-12.4
- Reported statistics and error estimates:
- LC50 values and 95 % confidence intervals were estimated using the trimmed Spearman-Karber method.
- Validity criteria fulfilled:
- not applicable
- Remarks:
- Non-guideline study, but scientifically robust result published in peer-reviewed article.
- Conclusions:
- The lowest 96 h LC50 value (worst-case approach) among fish of the guideline-recommended size (5.0 ± 1.0 cm) was 28.8 mg/L (95% C.I. = 27.0–30.7).
- Executive summary:
In a 96-h acute toxicity study, rainbow trout (Oncorhynchus mykiss, reported as Salmo gairdneri) were exposed to ammonium at measured concentrations (exact values not reported) under flow-through conditions. According to OECD 203 (OECD 1992) the recommended total length of test fish Oncorhynchus mykiss should be 5.0 ± 1.0 cm. Therefore, the results on fish in this size range as reported in the publication are used to describe the aquatic toxicity of ammonia to hatchery-reared rainbow trout. In a worst-case approach, the lowest among these LC50 values of 28.8 mg/L (NH3-N) is taken forward to the risk assessment. Sublethal effects were not reported.
This toxicity study is classified as acceptable and satisfies the guideline requirement for fish toxicity studies, with some reporting deficiencies that do not compromise the overall quality of the study.
Results synopsis
Test organism size (mean length): 5.0 ± 1.0 cm
Test type: Flow-through
LC50: 28.8 mg NH3/L (95 % C.I. = 27.0–30.7 mg/L)
Endpoint(s) effected: Mortality
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Endpoint:
- short-term toxicity to fish
- 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 attached report in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 180 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- >= 195 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mortality (fish)
- Details on results:
- Test solutions were not neutralised. It is more than likely that the low pH value affected the survival of the fish. At the highest test concentration a pH of 3.25 was measured.
- Sublethal observations / clinical signs:
The apparent toxicity of lactic acid to Brachydanio rerio can be explained by the low pH values of the test substance solutions. At the highest test concentration a pH of 3.25 was measured.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The LC50 of L-(+)-lactic acid to Danio rerio was determined to be > 195 mg/L (mean measured concentration), which can be attributed to a pH effect.
- Executive summary:
The acute toxicity of the test substance, a solution of about 80 % L-(+)-lactic acid, to the freshwater fish speciesBrachydanio reriowas determined according to OECD guideline no. 203 and under GLP.
The study was carried out as a semi-static test with daily replacement of the test solutions and with 10 fish for each concentration. The exposure duration was 96 hours. The nominal concentrations tested were 100, 180, 320, 560 and 1000 mg/L.
The test substance appeared to be completely dissolved at all concentrations tested (visually assessed). The actual concentrations of L-(+)-lactic acid were determined enzymatically with a Boehringer test kit. They were between 70 and 77 % of the nominal concentrations just after dosing (average 74 %). To test the stability the concentrations of L-(+)-lactic acid were also analysed just before renewal and were between 56 % and 82 % of nominal (average 72 %). Mean measured effect concentrations are thus obtained by correcting nominal test material concentrations by correcting for 80 % lactic acid concent and by the average 72 % measured values.
The results of the test were (as mean measured concentration of L-(+)-lactate):
96-h LC50 > 195 mg/L
96-h LC100 = 332 mg/L
96-h NOEC (mortality) = 104 mg/L
The apparent toxicity of lactic acid toBrachydanio rerio can be explained by the low pH values of the test substance solutions. At the highest test concentration a pH of 3.25 was measured.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Referenceopen allclose all
Description of key information
The potential toxicity of ammonium-S-lactate to fish is composed of contributions by both the S-lactate and the ammonium ion. In a short-term toxicity test on lactic acid mortality was observed resulting in estimated an LC50 value of > 195 mg/L (mean measured) which can be attributed to a pH effect. Lactate as such is considered not to exert any systemic effects on fish in the tested concentration range of up to 560 mg/L.
The toxicity of the ammonium ion to fish was determined in a series of 96-h tests, resulting in a lowest (most conservative) LC50 (96-h, Oncorhynchus mykiss) of 28.8 mg NH3-N/L (Thurston 1983). Accordingly, the potential toxicity of ammonium-S-lactate is solely determined by the ammonium ion. Stoichiometric conversion to ammonium-S-lactate results in an LC50 (96 h) of 222 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- ca. 222 mg/L
Additional information
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-acrross report attached to IUCLID section 13.
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.