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EC number: 253-518-6 | CAS number: 37475-84-6
- 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
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
In reproductive toxicity study performed according to the reproduction/developmental toxicity screening test [OECD TG 422], DDBSA did not cause any statistically significant differences in the following parameters examined: gestation length, the number of corpora lutea and implantation, delivery index, precoital time, fertility, mating data and in the histopathological examination. The NOAEL was 400 mg/kg bw/day in both sexes (highest dose tested).
In a reproduction screening study (OECD 421), dietary exposure of rats to 1000 mg/kg/day of AMP had no effect on mating performance or conception, but caused marked, dose-related increases in post-implantation loss (embryo resorption). At 1000 mg/kg bw, all 12 pregnant females showed evidence of complete litter resorption (100% post-implantation loss), while at 300 mg/kg/day, post-implantation loss was 70% (vs. 10% in controls). Effects associated with, or secondary to the post-implantation loss increase at 300 mg/kg/day included decreased litter size, increased pup body weight, and decreased gestation body weight and body weight gain. There were no treatment related effects on reproductive performance in the 100 mg/kg/day group.The no-observed effect level (NOEL) for general toxicity in males was 300 mg/kg/day, while the general toxicity NOEL for females could not be determined, based upon the presence of very slight microscopic liver effects. The NOEL for reproductive effects was considered to be 100 mg/kg/day.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Effects on reproduction as seen in the study on AMP were only observed at maternally toxic doses.
The NOAEL for reproduction is in a worst case set at the NOAEL of the most toxic component of the substance.
Effects on developmental toxicity
Description of key information
In reproductive toxicity study on DDBSA performed according to the reproduction/developmental toxicity screening test [OECD TG 422], the offspring delivered by chemical-treated rats had been observed until day 4 of postpartum. There were no statistically significant differences were seen in the following parameters: the number of live and dead pups, live pups/implantation ratio, dead pups/implantation ratio, pre-implantation loss, post-implantation loss, sex ratio, viability index, number of neonates with external anomalies, and body weights of pups on post-natal day 0 and day 4. There were no treatment-related changes in all parameters of offspring during the parturition and lactation periods and the NOAEL for developmental toxicity was 400 mg/kg bw/day for F1 pubs (highest dose tested).
In a study according to OECD 414, female rats were daily exposed to 1.0%, 5.0%, and 20% of LAS (20, 100, and 400 mg/kg bw DDBSA/day) in their diet during days 0 through 21 of gestation.
Maternal toxicity: the dams treated with 400 mg/kg bw/day and 100 mg/kg bw/day showed inhibition of body weight gain and local skin effects that compromised the integrity of the skin and caused overt toxicity, like inhibition of the body weight gain.
Effect on offspring: there were no findings indicative of effects of LAS on the foetal parameters evaluated (corpora lutea, implantations, viable foetuses or resorptions). No skeletal and visceral abnormalities were seen in any of the dose groups.
Dermal administration of 300 mg/kg/day of AMP produced significant effects at the test site, as evidenced by scabbing (77% affected) and moderate to severe scaling (35% affected). The dermal finding of slight scaling at 30 and 100 mg/kg/day was not considered adverse, as the observation was transient in nature and relatively low in incidence. There was no evidence of test article related systemic maternal or developmental toxicity at any dose level tested. Under the conditions of this study, the NOAEL for maternal toxicity based on dermal effects was 100 mg/kg/day. The NOEL for developmental toxicity was 300 mg/kg/day, the highest dose level tested. Analyses of blood samples confirmed systemic exposure to AMP in a dose-responsive manner, although the study was not designed to quantify percent absorption.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 400 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
No effect on development was reported in any of the studies available.
The NOAEL for developmental toxicity via the dermal route is in a worst case set at the NOAEL of the most toxic component of the substance. For the oral route no data on AMP is available, therefore the NOAEL of DDBSA is chosen as representative for the substance.
Justification for classification or non-classification
Based on the data on the components, the substance does not need to be classified for reproductive or developmental toxicity according to CLP (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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