Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-638-8 | CAS number: 90268-37-4
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 79.34 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 380 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Key oral OECD 422 toxicity study available; no repeated dose inhalation toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor. The factor for duration will become updated with new studies in near future. See justification attached
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default factor.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 1
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 56.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Key oral OECD 422 toxicity study available; no repeated dose dermal toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor. The factor for duration will become updated with new studies in near future. See justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default factor.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 1
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNELs were based upon following source information:
- A key subacute OECD No. 422 study was conducted with the registered substance in Wistar rats (12/sex/group) by oral gavage at 0 (distilled water), 60, 150 and 450 mg/kg bw/day (Hargitai, 2022). Parameters measured during the study included twice a day mortality checking, daily routine and weekly detailed observation of clinical signs, weekly body weight and food consumption measurements and clinical pathology evaluation (including haematology, coagulation, clinical chemistry and urinalysis). Neurological assessment (Functional Observation Battery (FOB) including measurements of the landing foot splay, grip strength as well as locomotor activity measurement) was performed during the last week of the treatment for each sex. Reproductive performance is reported under Section 7.8. At termination (Day 28 for males, PPD (Post-partum Day) 14 for females), necropsy with macroscopic examination was performed. Weights of selected organs were recorded, and representative tissues/organs were sampled and preserved in appropriate fixatives from the adult animals or F1 animals. The thyroxine (T4) levels in the PND (Post-natal Day) 13 pups and parental males were also determined. For the adult animals, a detailed histological examination was performed on the selected list of retained organs of 5 animals/sex in the Control and High dose groups, the retained reproductive organs of all Control and High dose animals, stomach and thymus from all animals, the found dead animal or all organs with relevant macroscopic changes, and the male / female mating pair where no liveborn pups were achieved. Dosing formulations were analysed for concentration and/or homogeneity on three occasions during the study. Overall, the formulations were considered adequate for the study. In summary, under the conditions of this study the daily administration of TENSOMILD H026 (containing Disodium lauryl sulfosuccinate (EC 939-638-8) as active ingredient) by oral gavage to Wistar rats at dose levels of 60, 150 or 450 mg/kg bw/day (Low, Mid and High dose groups, respectively) did not result in test item related mortality or clinical signs. Test item related adverse effect was observed on body weight parameters and food consumption in High dose (450 mg/kg bw/day) males. At the functional observation battery (FOB) and locomotor activity measurement, there were no changes in animal behaviour, general physical condition or in the reactions to different type of stimuli in test item treated groups when compared to control. No test item-related adverse effects were seen in the clinical pathology parameters. Increased liver weights in High dose females (450 mg/kg bw/day) were not confirmed at histopathology, but adaptive hypertrophy of 11-14% as seen in this study is often not visible at histopathology; the organ weight difference was considered as non-adverse. Test item-related changes were observed in the non-glandular stomach in both sexes of the Mid and High dose groups (150 and 450 mg/kg bw/day, respectively) with a dose dependent trend in incidence and severity, indicating local irritation by the test item; males were more affected. The changes in the non-glandular stomach observed in this study were considered due to the irritant nature of the test item and is considered as a local effect rather than systemic toxicity of the test item.
Based on the existing results of this study, the following No-Observed-Adverse-Effect Levels (NOAELs) were considered: The NOAEL for systemic toxicity of the parental generation: 150 mg/kg bw/day (based on body weight and food consumption effects in males at 450 mg/kg bw/day). The NOAEL for local toxicity of the parental generation: 60 mg/kg bw/day (based on the local irritation in the stomach in both sexes in the 150 and 450 mg/kg bw/day dose groups).
- A 90-day study was not available for the registered substance, however read across data were available from read-across substance in the same subgroup, CAS No. 37294-49-8 (disodium C-isodecyl sulphonatosuccinate). This key study for subchronic toxicity was performed in rats with test item containing ca. 50% active ingredient (Tegeris and Underwood, 1975) at 0.25%, 1.00% and 4.00% in the diet (corresponding to mean calculated test article intake of 188, 750 and 3000 mg act.ingr./kg bw/day). At the highest dose levels, it caused a significant difference in body weight gain, most probably related to an effect by the compound during absorption from the gastro-intestinal tract. There was one mortality in the high dosed females. Haematology and serum analysis also indicated toxicity at the high dose, whereas at the medium dose, only some organ-to-body weight changes were observed (e.g. liver weight increases in both sexes). Other organ-to-body weight changes were also observed at the high dose group (e.g. slightly decreased gonad weights in males; decreased gonad weight in females); increased relative kidney weights were observed in all female dose groups. Chronic renal disease (mild) was observed in 1/20 males and 6/20 females of the high dose groups. The high dose was considered to be toxic, whereas the changes of the medium dose may be considered adaptive. Therefore 1% (750 mg/kg bw/day) may be considered as NOAELand 0.25% (174 mg/kg bw/day) as NOEL.
- Subchronic toxicity testing with read-across substance CAS No. 90268-36-3 is planned and will be updated later when results are available (currently waived in the dossier).
- For risk assessment, the lowest NOAEL of 150 mg/kg bw/day with registered substance tested in the OECD 422 study was selected as dose descriptor for calculation of long term systemic DNELS. This approach was considered conservative, as the NOAEL with read across substance in subchronic study with dietary administration was much higher. Further justification of assessment factors is explained in the DNEL justification document attached to the endpoint summary.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19.57 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature.
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 174 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Key oral OECD 422 toxicity study available; no repeated dose inhalation toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor. The factor for duration will become updated with new studies in near future. See justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 1
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 28.13 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Key oral OECD 422 toxicity study available; no repeated dose inhalation toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor. The factor for duration will become updated with new studies in near future. See justification attached
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 1
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.63 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor. The factor for duration will become updated with new studies in near future. See justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 1
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNELs were based upon following source information:
- A key subacute OECD No. 422 study was conducted with the registered substance in Wistar rats (12/sex/group) by oral gavage at 0 (distilled water), 60, 150 and 450 mg/kg bw/day (Hargitai, 2022). Parameters measured during the study included twice a day mortality checking, daily routine and weekly detailed observation of clinical signs, weekly body weight and food consumption measurements and clinical pathology evaluation (including haematology, coagulation, clinical chemistry and urinalysis). Neurological assessment (Functional Observation Battery (FOB) including measurements of the landing foot splay, grip strength as well as locomotor activity measurement) was performed during the last week of the treatment for each sex. Reproductive performance is reported under Section 7.8. At termination (Day 28 for males, PPD (Post-partum Day) 14 for females), necropsy with macroscopic examination was performed. Weights of selected organs were recorded, and representative tissues/organs were sampled and preserved in appropriate fixatives from the adult animals or F1 animals. The thyroxine (T4) levels in the PND (Post-natal Day) 13 pups and parental males were also determined. For the adult animals, a detailed histological examination was performed on the selected list of retained organs of 5 animals/sex in the Control and High dose groups, the retained reproductive organs of all Control and High dose animals, stomach and thymus from all animals, the found dead animal or all organs with relevant macroscopic changes, and the male / female mating pair where no liveborn pups were achieved. Dosing formulations were analysed for concentration and/or homogeneity on three occasions during the study. Overall, the formulations were considered adequate for the study. In summary, under the conditions of this study the daily administration of TENSOMILD H026 (containing Disodium lauryl sulfosuccinate (EC 939-638-8) as active ingredient) by oral gavage to Wistar rats at dose levels of 60, 150 or 450 mg/kg bw/day (Low, Mid and High dose groups, respectively) did not result in test item related mortality or clinical signs. Test item related adverse effect was observed on body weight parameters and food consumption in High dose (450 mg/kg bw/day) males. At the functional observation battery (FOB) and locomotor activity measurement, there were no changes in animal behaviour, general physical condition or in the reactions to different type of stimuli in test item treated groups when compared to control. No test item-related adverse effects were seen in the clinical pathology parameters. Increased liver weights in High dose females (450 mg/kg bw/day) were not confirmed at histopathology, but adaptive hypertrophy of 11-14% as seen in this study is often not visible at histopathology; the organ weight difference was considered as non-adverse. Test item-related changes were observed in the non-glandular stomach in both sexes of the Mid and High dose groups (150 and 450 mg/kg bw/day, respectively) with a dose dependent trend in incidence and severity, indicating local irritation by the test item; males were more affected. The changes in the non-glandular stomach observed in this study were considered due to the irritant nature of the test item and is considered as a local effect rather than systemic toxicity of the test item.
Based on the existing results of this study, the following No-Observed-Adverse-Effect Levels (NOAELs) were considered: The NOAEL for systemic toxicity of the parental generation: 150 mg/kg bw/day (based on body weight and food consumption effects in males at 450 mg/kg bw/day). The NOAEL for local toxicity of the parental generation: 60 mg/kg bw/day (based on the local irritation in the stomach in both sexes in the 150 and 450 mg/kg bw/day dose groups).
- A 90-day study was not available for the registered substance, however read across data were available from read-across substance in the same subgroup, CAS No. 37294-49-8 (disodium C-isodecyl sulphonatosuccinate). This key study for subchronic toxicity was performed in rats with test item containing ca. 50% active ingredient (Tegeris and Underwood, 1975) at 0.25%, 1.00% and 4.00% in the diet (corresponding to mean calculated test article intake of 188, 750 and 3000 mg act.ingr./kg bw/day). At the highest dose levels, it caused a significant difference in body weight gain, most probably related to an effect by the compound during absorption from the gastro-intestinal tract. There was one mortality in the high dosed females. Haematology and serum analysis also indicated toxicity at the high dose, whereas at the medium dose, only some organ-to-body weight changes were observed (e.g. liver weight increases in both sexes). Other organ-to-body weight changes were also observed at the high dose group (e.g. slightly decreased gonad weights in males; decreased gonad weight in females); increased relative kidney weights were observed in all female dose groups. Chronic renal disease (mild) was observed in 1/20 males and 6/20 females of the high dose groups. The high dose was considered to be toxic, whereas the changes of the medium dose may be considered adaptive. Therefore 1% (750 mg/kg bw/day) may be considered as NOAEL and 0.25% (174 mg/kg bw/day) as NOEL.
- Subchronic toxicity testing with read-across substance CAS No. 90268-36-3 is planned and will be updated later when results are available (currently waived in the dossier).
- For risk assessment, the lowest NOAEL of 150 mg/kg bw/day with registered substance tested in the OECD 422 study was selected as dose descriptor for calculation of long term systemic DNELS. This approach was considered conservative, as the NOAEL with read across substance in subchronic study with dietary administration was much higher. Further justification of assessment factors is explained in the DNEL justification document attached to the endpoint summary.
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.