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Diss Factsheets
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EC number: 296-719-4 | CAS number: 93028-28-5
- 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
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Endpoint summary
Administrative data
Description of key information
The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. Effects observed by oral exposure demonstrate a reduction in serum cholesterol at the highest tested dose. Furthermore, the results obtained by inhalation exposure are considered unsafe for determination of the intrinsic hazard of the substance by inhalation due to the a high proportion (65%) of mineral oil in the test sample.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 881.58 mg/m³
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 881.58 mg/m³
- Study duration:
- subacute
- Species:
- rat
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
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/cm²
- Study duration:
- subacute
- Species:
- rat
Additional information
The repeat dose toxicity has been determined by subacute 28-day oral toxicity studies by oral, dermal and inhalation exposure. Based on the data available, the substance may have the potential for haemotological effects with a reduction in cholesterol observed in one of the studies by oral exposure.
Effects observed in the repeat dose inhalation toxicity study available demonstrated enlarged lungs in high and intermediate dose animals which are likely to be physical effects due to the inhalation of mineral oil [Test material: Product as manufactured in mineral oil solvent further diluted in mineral oil (65/35)] and not necessarily a direct toxicological effect of the registered substance. The data are therefore considered unsuitable for determination of the intrinsic hazard of the substance as effects due to the registered substance may well be masked by the effects due to inhalation of mineral oil mist. For example, Occupation Exposure Limits (OELs) expressed for human exposure in the work place are typically 5 mg/m³. Considering a typical intraspecies assessment factor of 10 the results demonstrate good correlation to the anticipated effect level for mineral oil mist.
In view of this it is considered justifiable, for the purposes of assessing DNELs, to extrapolate inhalation hazard from the oral exposure data available.
Oral-to-inhalation extrapolation was based on the following conditions:
(1) the available repeated dose toxicity study on EC 274-263-7 was reliable;
(2) the critical effect for the oral exposure were systemic, i.e., decreased serum cholesterol levels;
(3) the considered systemic toxic effects was independent of the route of exposure;
(4) the chemical is relatively soluble in body fluid.
RtR extrapolation may require corrections for difference in absorptions between oral (starting route) and the inhalation (extrapolation route) (Dethloff, L. Z. 1993; Gerrity T. R., 1990; Sharrat M. 1988). Rennen et al. ran a critical assessment on oral-to-inhalation route extrapolation for 215 substances with various physicochemical properties. In this study, they compared the experimentally established NOAEL for inhalation study to the values predicted from oral toxicity study by RtR extrapolation using various absorption assumptions, such as 100% oral and 100% inhalation; 100% oral and 75% inhalation; 50% oral and 100% inhalation. And they demonstrated that when using systemic effect as criterion and under assuming equal absorption, 55% of the predication were regarded as “safe extrapolation”, whereas 45% as underestimation of the level of toxicity via inhalation route. Based on this study, it is feasible to assume that equal absorption for this substance. Correcting from oral to inhalation route of exposure was based on REACH guidance R8, and the mathematic formula was described in DNEL derivations.
Furthermore, one dermal repeat dose study exists noting effects which resulted in the Study Director being unable to assign a NOAEL. Due consideration of these data has been taken, but the results are considered not representative of the toxicological effects of the substance since the observations have not been repeated in the remaining study with dermal exposure, nor following exposure by oral and inhalation routes which are generally considered to represent greater systemic exposure routes. Furthermore, effects to the testes of male rats were not been observed in the reproductive toxicity study. In consequence, although data are not available to adequately determine the cause of these effects, the fact that no similar observations have been found in any other study undertaken is considered adequate justification to regard these data as not representative of the toxicological profile of the registered substance.
Notwithstanding these effects, no further effects were observed in the studies and each study achieved a NOAEL. The data are therefore considered adequate to assess the toxicological profile of the substance and for the purposes of classification.
The following information is taken into account for any hazard / risk assessment:
The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. Effects observed by oral exposure demonstrate a reduction in serum cholesterol at the highest tested dose. Furthermore, the results obtained by inhalation exposure are considered unsuitable for determination of the intrinsic hazard of the substance by inhalation due to the high proportion of mineral oil in the test sample [Test material: Product as manufactured in mineral oil solvent further diluted in mineral oil (65/35)].
Value used for CSA (route: oral):
NOAEL: 500 mg/kg bw/day (subacute; rat)
Target organs: cardiovascular / hematological: other: serum cholesterol
Value used for CSA (route: dermal):
NOAEL: 1000 mg/kg bw/day (subacute; rat)
Value used for CSA (route: inhalation):
NOAEC: 881.58 mg/m³ (subacute; rat)
Target organs: respiratory: cardiovascular / hematological: other: serum cholesterol
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Data from two studies are available with exposure by oral gavage to linear and branched alkaryl benzene sulphonates upto a maximum dose of 1000 mg/ml/day. Relatively slight effects were observed in either study, limited to a reduction in cholesterol in serum at high dose animals only in one study. The lowest dose at which no adverse effects were observed effects were observed is, therefore, taken as the appropriate effect level.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The data from only one repeat dose toxicity test by the inhalation route is available. The test substance is, however, extremely difficult to test by this route and, due to the nature of the substance in mineral oil, any effects due to the test sample are masked by the effects of the mineral oil. The NOAEC is, therefore, determined by extrapolation to oral exposure.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
The data from only one repeat dose toxicity test by the inhalation route is available. The test substance is, however, extremely difficult to test by this route and, due to the nature of the substance in mineral oil, any effects due to the test sample are masked by the effects of the mineral oil. The NOAEC is, therefore, determined by extrapolation to oral exposure.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The data from two studies are available to assess dermal toxicity by repeated dose. No systemic toxicity was observed in either study.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Effects of skin irritation were observed by repeated exposure. The effects were relatively slight.
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other
Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: lung
Justification for classification or non-classification
Based on the NOAEL values available from these data, the substance is considered to be not classified under CLP
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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