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EC number: 806-731-9 | CAS number: 1428353-74-5
- 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
The assessment is based on a weight of evidence using test material, CAS RN 63310-16-7, which was determined to have a NOAEL of 1000 mg/kg/day in a 28 day repeat dose study performed in accordance with OECD 410.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study was conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. It was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997).
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No repeated dose studies are available for the registered substance. However, repeat dose data is available for the raw materials, which are also the potential breakdown products.
The dermal repeat dose toxicity of CAS RN 63310-16-7 was determined following a methodology equivalent to standardised guideline OECD 410. Groups of fifteen male and fifteen female rats were dermally administered 20% w/w, 50% w/w or 100% test material in mineral oil for a period of 4 weeks. Animals were treated for 6 hours per day, six times a week during week 1, five time per week during weeks 2 and 3 and four times a week during week 4. An additional group of fifteen males and fifteen females were treated with mineral oil alone and served as controls. Clinical observations, bodyweights and skin irritation parameters were measured throughout the study. At the end of the scheduled period, the animals were killed and subjected to an examination post mortem. Cardiac blood samples were taken for clinical pathology, selected organs were weighed and specified tissues were taken for subsequent histopathology examination. Under the conditions of the study, subacute dermal treatment of male and female rats with test material did not cause any mortality or any signs of toxicity. Mild skin irritation appeared in both sexes during the first week of the study, but subsided thereafter. The statistically significant changes in mean serum calcium levels, serum phosphorus levels, blood urea nitrogen , blood urea nitrogen/creatinine ratios, left ovary weight, left ovary/body weight ratio and brain weight were not considered biologically significant. No other significant changes occurred that could be attributed to treatment with the test material. The No Observed Adverse Effect Level was subsequently determined to be 1000 mg/kg bw/day.
Dermal repeated dose studies (14 week and 104 week) were conducted on rats and mice using CASRN 68603-42-9 (NTP, 2001). Results in the table below highlight that the NOAEL for systemic toxicity was not established based on changes in organ weights at 25 mg/kg/day and above. Additionally, local irritation was reported at 25 mg/kg/day for all studies and the NOAEL was not established.
CAS Number | Repeat Dose Studies | Reference |
68603-42-9 | 14-week Rat (F344/N):0, 25, 50, 100, 200 or 400 mg/kg/day LOAEL (local irritation) = 25 mg/kg/day NOAEL (local irritation) = Not established NOAEL (systemic toxicity, males) = 400 mg/kg/day(highest dose tested) LOAEL (systemic toxicity, females) = 25 mg/kg/day(based on absolute kidney weight changes) NOAEL (systemic toxicity, females) = Not established Similar to OECD 411
104-week Rat (F344/N):0, 50 or 100 mg/kg/day LOAEL (local irritation) = 50 mg/kg/day NOAEL (local irritation) = Not established NOAEL (systemic toxicity, males) = 100 mg/kg/day(highest dose tested) LOAEL (systemic toxicity, females) = 50 mg/kg/day(based on increased incidence of renal tubule hyperplasia) NOAEL (systemic toxicity, females) = Not established | NTP, 2001; EPA FND, 2010
|
14-week Mouse (B6C3F1):0, 50, 100, 200, 400 or 800 mg/kg/day LOAEL (local irritation) = 50 mg/kg/day NOAEL (local irritation) = Not established LOAEL (systemic toxicity) = 400 mg/kg/day(based on increased liver and kidney weight) NOAEL (systemic toxicity) = 200 mg/kg/day Similar to OECD 411
104-105 weekMouse (B6C3F1):0, 100 or 200 mg/kg/day LOAEL (local irritation) = 100 mg/kg/day NOAEL (local irritation) = Not established NOAEL (systemic toxicity) = Not established (organ weights, basis for NOAEL in 14-week study, were not measured) | NTP, 2001; EPA FND, 2010
| |
63310-16-7 | No target organ effects, 3 NOEL = ca. 1.0 ml/kg (highest dose tested) Similar to OECD 407 | Dukeet al.,1982 |
The dermal repeat dose study with CAS RN 63310-16-7 is used as the authoritative study for classification and risk assessment purposes. Dermal exposure is the only anticipated potential route of exposure; therefore, the borated glycerol ester, which is represented by CAS RN 63310-16-7 is the most relevant toxicology functionality and closest analog.
REFERENCES
Duke, C.E., Cisson, C.M., and Wong, Z.A. 1982. Twenty-eight Day Repeated Dermal Study of[redacted]in Adult Male and Female Rats. Internal Chevron Environmental Health Center. Report No. SOCAL 1873.
Fatty Nitrogen Derived (FND) Amide Category EPA Hazard Characterization. 2010.
National Toxicology Program (NTP). 2001. “Diethanolamine Condensate (CAS No. 68603-42-9) in F344/N Rats and B6C3F1 Mice (Dermal Studies)”. NTP TR 479/NIH. Publication No. 01-3969.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Currently, there is no existing repeat dose toxicology data on the registered substance (CASRN 1428353-74-5); however, acute dermal toxicity data exist for borated glycerol monooleate (CASRN 63310-16-7) and one of the breakdown products of the registered substance amines, coco, N, N-bis (hydroxyethyl) (CASRN 68603-42-9). The read across repeated dose toxicity data demonstrates that the substance to be registered is not expected to be toxic following repeated dermal exposure.
Justification for classification or non-classification
In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for specific organ toxicity, repeated dose. The effects observed in the available study are not considered to be toxicologically significant and do not indicate any signs of organ dysfunction.
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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