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EC number: 442-490-2 | CAS number: 871-70-5 EMEROX 118
- 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
Acute toxicity:
- oral: LD50 > 5000 mg/kg bw
- dermal LD50 > 5000 mg/kg bw
Key value for chemical safety assessment
Additional information
Oral: Acute oral toxicity of octanoic acid was analyzed in a study
performed under GLP according to OECD guideline 401. In this limit test
5 male and 5 female Wistar rats received a dose of 5000 mg/kg bw
octanoic acid by gavage. No signs of systemic toxicity and no change in
body weight gain were observed during the 14 day observation period.
Macroscopic examination of animals at termination revealed only, firm
and/or small white/greyish irregular patches in the forestomach of all
animals. Since no mortality occurred, the LD50 was found to be >5000
mg/kg bw.
In another study conducted under GLP in accordance with OECD guideline
401, 5000 mg/kg bw for long chain fatty acid was administered by gavage
to 5 male and 5 female Wistar rats (Kästner, 1981). After administration
the animals showed salivation, reduced breathing and activity and
reduced state, while in females also ataxia, lateral position, reduced
corneal reflex were observed. However, all animals were free of symptoms
from 24 hours on. Since no mortality occurred, the LD50 was found to be
>5000 mg/kg bw.
Due to the structural and toxicological similarities of members within
the category including 18 Di (871 -70 -5) the same result is has been
determined. Acute oral toxicity of CAS
871-70-5 octadecanedioic acid was evaluated in a test with rats
performed similar to OECD Guideline 401. Ten animals received an oral
application of 5000 mg/kg bw of the substance with corn oil. Two female
animals have not survived with GI tract solid blockage; all other
animals showed no clinical symptoms during the observation period and
the no substance-related findings were observed at gross pathology. The
survived animals showed also normal weight and gain during the study.
Based on these results and considering the physical GI tract blockage,
the LD50 was found to be > 5000 mg/kg bw.
Inhalation route is not relevant because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance - (annex VIII column 2 of REACH regulation) Data from the other two exposure routes (oral and dermal) are available.
Dermal:
A general prerequisite for systemic toxicity after dermal
application is the permeability of the skin for the applied substance.
Although the dermal penetration of fatty acids is very variable, in
general they do not have significant systemic bioavailability (for
details see IUCLID chapter 7.1).
Thus, no acute dermal toxicity by fatty acids is expected as it could be
demonstrated by a LD50 value of >2000 mg/kg bw for C18 fatty acid
(stearic acid) found in a in limit test performed according to internal
company standards (Jones, 1979). Three male and three female New Zealand
White rabbits received a dermal application of 2000 mg/kg bw stearic
acid to 25% of the total body surface under occlusion for 24 hours. As
result, slight diarrhoea was noted in one female animal on day 3 after
treatment. All other animals appeared normal throughout the observation
period. Laboured breathing on day 6 was noted in one male, which died
the next day. Although the pathological examination revealed severe
consolidation of the lungs, this finding was not considered to be
substance related. Irritating effects were noted on the skin of all
animals which were described as ranging from slight to severe. Four
animals showed slight and moderate desquamation. Slight oedema and
eschar formation were also noted in some animals during the first week
of observation. However, these observed effects can be attributed to the
severe conditions used for application which are not in line with
current guidelines. However, a LD50 of >2000 mg/kg bw was found for
stearic acid.
Although the dermal absorption of C18 fatty acid (stearic acid) with
0.00026 mg/cm2is lower compared to fatty acids with shorter chain
lengths (e.g. C12 fatty acid: 0.005 mg/cm2), even single or repeated
oral uptake of C12 fatty acid does not lead to systemic effects due to
the physiological function within the body.
Moreover, dermal exposure can be considered to be sufficiently
controlled in industrial and professional applications since the
employees are wearing gloves and protective clothing. Thus, no acute
dermal toxicity by fatty acids is expected and no further testing shall
be performed due to animal welfare reasons.The
dermal LD 50 of the test substance CAS 871-70-5 octadecanedioic acid is
>5000 mg/kg bw.
In conclusion, based on available data on various representative substances within the category, no acute dermal toxicity of fatty acids are expected.
Justification for classification or non-classification
According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute toxicity, 1,18 octadecanedioic acid does not fulfill the criteria for classification and thus a non-classification is warranted for this endpoint.
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