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EC number: 204-375-3 | CAS number: 120-18-3
- 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
oral
28 d rat, drinking water; TS: naphthalenesulfonic acids, sodium salt: NOAEL systemic toxicity >= 1835 mg/kg bw/ day due to not observed adverse effects (OECD 407, GLP; BASF AG 1995)
15 w rat, diet; TS: naphthalenesulfonic acids, potassium salt: NOAEL systemic toxicity >= 1000 mg/kg bw/ day due to not observed adverse effects (OECD 415/416, GLP; BASF AG 2003)
dermal
no data available
inhalation
no data available
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The toxicity of naphthalene-2 -sulfonic acid after repeated oral dosing can be assessed by reliable studies which were performed with the respective sodium and potassium salts.
oral
In a GLP conform subchronic study according to OECD test guideline 407, naphthalenesulfonic acids, sodium salt (purity 82%) was administered to groups of 5 male and 5 female Wistar rats in drinking water at concentrations of 0 ppm; 600 ppm 3,000 ppm and 15,000 ppm for 4 weeks (BASF AG, 1995).
Food consumption and body weight were determined each week. The animals were examined for evident signs of toxicity or mortality at least once a day. During the weekly weighing the animals were subjected to an additional comprehensive clinical examination. Urinalyses, clinicochemical and hematological examinations were carried out at the end of the administration period. All animals were subjected to gross-pathological assessment, followed by histopathological examinations.
The mean daily test substance intake was about 62; 331; and 1835 mg/kg bw, respectively.
No substance-related findings were obtained. There was also no indication for neurotoxic effects. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore >= 1835 mg/kg body weight.
In a reproductive study according to GLP requirements, naphthalene sulfonic acids, potassium salts (purity 99.9%) were administered to groups of 25 male and 25 female healthy young Wistar rats (FO parental generation) as a homogeneous addition to the food in different dietary concentrations, which were adjusted regularly to obtain a constant test substance intake of 0, 100, 300 and 1000 mg/kg bw/day (BASF AG 2003). The study followed OECD test guideline 415 with observation of additional reproductive parameters (extended one-generation study). The F0 animals were treated for ca. 15 weeks.
The study was terminated with the sacrifice and gross necropsy of all F0 animals. The state of health of the F0 rats was checked each day. Water consumption of the F0 parents was determined regularly during the first 10 weeks after the start of the respective study period (once weekly generally over a period of 3 days each), and additionally during gestation for days 0-1, 6-7, 13-14, and 19-20 p .c. (post coitum) and during lactation periods for days 1-2, 4-5, 7-8, and 14-15 p .p . (p.p. = post partum) of the F0 females. Food consumption of the F0 parents was determined regularly during premating (once weekly over a period of 6 days each), and during gestation (days 0-7, 7-14, 14-20) and lactation periods (days 1-4, 4-7, 7-14). In general, body weights of F0 parent animals were determined once weekly (each time for a period of 7 days). However, F0 females were weighed on days 0, 7, 14 and 20 of gestation and on days 1, 4, 7, 14 and 21 of lactation. Blood and urine samples were taken from 12 F0 parental animals per sex and per group shortly before terminal sacrifice. In the F0 animals of both genders organ weights were determined and histopathological examinations were performed in selected organs. Particular attention was focused to the reproductive organs. The measured intakes of NSA potassium salts by the different test groups correlated well with the desired target concentrations.
The following test substance-related findings were observed:
Decreased total bilirubin was observed in both sexes in the high dose group (-24% males; - 33% females) and in the mid dose group (-13% males; - 22% females), but not in the low dose group. The clinical, gross and histopathological examinations as well as organ weight determinations of the F0 parental rats for general signs of toxicity failed to reveal substance-induced effects up to and including the dose of 1,000 mg/kg body weight/day. The isolated findings on bilirubin concentrations are probably associated with the test compound administered. In the absence of any other sign of systemic toxicity, in particular of clinical pathological and pathological alterations, however, the observed decrease in serum bilirubin concentration has no pathognomonic or toxicological relevance.
Thus, under the conditions of the present extended one-generation study the NOAEL (no observed adverse effect level) of 1,000 mg/kg body weight/day could be fixed for the systemic toxicity of the test substance. In addition, there was no indication for neurotoxic effects of the test substance.
dermal
no data available
inhalation
no data available
Read across justification:
The registration item contains ca. 78.89% of naphthalene-2-sulphonic acid (CAS # 120-18-3) and ca. 6.5 % of naphthalene-1-sulphonic acid (CAS # 85-47-2). These two substances have the same molecular weight and are structurally almost identical. Therefore naphthalene-2-sulphonic acid and naphthalene-1-sulphonic acid and their respective salts are suitable for read across in order to fulfill the data requirements.
Justification for classification or non-classification
Regarding the results of the reliable studies with the respective sodium and potassium salts, the subchronic NOAEL of naphthalenesulfonic acids is considered to be >= 1000 mg/kg bw. due to the missing of adverse effects in the tested doses.
There are no indications given to classify naphthalenesulfonic acids for its repeated toxicity.
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