Registration Dossier
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EC number: 937-237-2 | CAS number: 1370006-50-0
- 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
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
In the 91-days repeat dose study, Sprague-Dawley rats were treated with partially unsaturated IQAC, DMS quaternised (tallow fatty acids) by application in the feed at doses of up to 1000 mg/kg bw/d of active ingredient. No treatment related effects were observed on the reproductive organs of either gender. Fertility studies are not available and not necessary at the production volume of this substance. Also, the dossier contains either the results of, or a testing proposal for, a pre-natal developmental toxicity study.
For derivation of worker and consumer DNELs an additional assessment factor of 2 has been used to account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs, resulting in a DNEL for workers (DNEL worker fertility dermal route systemic of 20.8 mg/kg bw/day) and DNELs for general population (DNEL general population fertility dermal route systemic of 12.5 mg/kg bw/day and DNEL general population fertility oral route systemic of 12.5 mg/kg bw/day). The oral exposure of workers with this substance family can be practically excluded and this is also the case for the general public as these industrial cleaners are not used in home care products or as constituents of cleaning agents in house hold products.
The dermal exposure is limited by the irritative properties of this substance family which will limit inadvertent dermal uptake.
Inhalation uptake via vapours can be excluded due to the very low vapor pressure of this substance family, which is approx. 7.5 x 10E-22 kPa.
For workers with a risk to aerosol inhalation with the undiluted test substance, personal protective equipment will be in place to avoid respiratory exposure with a priority on avoidance of respiratory tract irritation.Short description of key information:
Concerning fertility there are no animal studies specifically investigating this endpoint. However, no effects on organ weights of ovary and testes and histopathology of gonads from a 91-day repeated dose study were reported. There is no information available in humans.
Assessment of effects on fertility via inhalation is not applicable due to the very low vapour pressure of the test substance and the absence of aerosols.
Effects on developmental toxicity
Description of key information
Partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) was administered to 25 female Sprague CD rats/dose by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw /day of partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) /kg bw/day referring to 100 % active substance) from day 6 through 15 of gestation. The maternal NOEL is 1000 mg active substance/kg bw/day, based on the lack of effects indicating maternal toxicity.Likewise, the embryotoxic NOEL is 1000 mg active substance/kg bw/day, based on the lack of embryotoxic effects up to the highest dose level.The teratogenic NOEL is 1000 mg active substance/kg bw/day.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The test item partially unsaturated IQAC, DMS quaternised (tallow fatty acids, 75 %) possessed no teratogenic properties, not even at the highest dose tested. Embryotoxicity was not observed. Therefore the NOEL was 1000 mg partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) active ingredient/kg bw/day. The NOEL for maternal toxicity was 1000 mg partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) active ingredient/kg bw/day based on the lack of effects indicative of maternal toxicity.
Justification for classification or non-classification
There is no evidence for an intrinsic toxicity to reproduction of partially unsaturated IQAC, DMS quaternised from the results of a reliable oral developmental toxicity / teratogenicity study on rats at doses including the guideline limit dose of 1000 mg a. i./kg bw/day and reliable oral sub-chronic repeated dose toxicity data, where no treatment related effects were observed on the reproductive organs of either gender at 1000 mg/kg bw/day.
Therefore no classification is required for toxicity to reproduction according to CLP, EU GHS (Regulation (EC) No 1272/2008) and directive 67/548/EEC.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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