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EC number: 604-638-6 | CAS number: 148520-82-5
- 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
Repeated dose toxicity - oral: No key repeated dose toxicity study with the target substance is available. Data from the supporting substance LABS Na was used to cover this endpoint. In a 28days repeated dose toxicity, LABS Na was dosed in male and female Sprague-Dawley rats via oral gavage at doses up to 500 mg/kg bw/day. The NOAEL and LOAEL were set at 125 and 250 mg/kg bw/day, respectively. In the key chronic toxicity study, LABS Na was dosed daily via diet during 6 months. The NOAEL and LOAEL were set at 40 and 115 mg/kg bw/day, respectively.
Repeated dose toxicity - inhalation: No key repeated dose toxicity study via inhalation administration is available.
Repeated dose toxicity - dermal: No key repeated dose toxicity study via dermal administration is available.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female rats were exposed to LABS Na via gavage daily for 28 days.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- CAS number 69669-44-9
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- one month
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Information as cited in IPCS document. 12 animals per dose group.
- Control animals:
- yes, concurrent no treatment
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Diarrhea was observed in the 500 mg/kg group and soft stools were observed in the other 2 groups.
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain was suppressed in all the male groups and in the female 500 mg/kg group.
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological examinations revealed no abnormalities.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Serum-biochemical examinations revealed several differences among the mid and high dose group compared to the control group.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The weight of the spleen and the heart significantly decreased in the male high dose group. In the female high dose group, the weight of the liver increased while the weight of the heart and thymus decreased.
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histological findings of the liver revealed no abnormalities.
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 125 other: mg/kg bw d
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Serum-biochemical differences
- Dose descriptor:
- LOAEL
- Effect level:
- 250 other: mg/kg bw d
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Serum-biochemical differences
- Critical effects observed:
- not specified
- Conclusions:
- The test substance is considered to have a NOAEL = 125 mg/kg bw/day; LOAEL = 250 mg/kg bw/day.
- Executive summary:
Male and female rats were exposed to Na-LAS via gavage daily for 28 days. Body weight gain was suppressed, some serum biochemical measures were different from the controls, and some organ weights were either decreased (spleen, heart, thymus) or increased (liver) in either the male or female high dose groups. No mortalities or histopathological abnormalities were observed. The resultant LOAEL and NOAEL values were 250 and 125 mg/kg bw/day, respectively.
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female rats were exposed to LABS Na in the diet daily for 6 months.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- C10-14 LAS, sodium salt (CAS #69669-44-9)
C 10 10.6%, C 11 34.1%, C 12 27.7%, C 13 19.0% C 14 8.7%;
average alkyl chain length = C11.8;
mean molecular weight: 345.8 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- six months
- Frequency of treatment:
- daily in feed
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Remarks:
- 0.07%
- Dose / conc.:
- 115 mg/kg bw/day (nominal)
- Remarks:
- 0.2%
- Dose / conc.:
- 340 mg/kg bw/day (nominal)
- Remarks:
- 0.6%
- Dose / conc.:
- 1 030 mg/kg bw/day (nominal)
- Remarks:
- 1.8%
- No. of animals per sex per dose:
- Information as cited in IPCS document. 12 animals per dose group.
- Control animals:
- yes, concurrent no treatment
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- The 1.8% group showed diarrhea, markedly suppressed growth, increased weight of the cecum, and remarkable degeneration of the renal tubes. the 0.6% group showed slightly suppressed growth, increased weight of the cecum, increased activity of serum alkaline phosphatase (ALP), a decrease in serum protein and degeneration of the renal tubes. The 0.2% group showed increased weight of the cecum and slight degeneration of the renal tubes. The 0.07% group showed no adverse effects related to the administration of LAS. The intake of LAS in the 0.07% group was about 40 mg/kg bw/d.
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased weight of the cecum and slight degeneration of the renal tubes
- Dose descriptor:
- LOAEL
- Effect level:
- 115 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased weight of the cecum and slight degeneration of the renal tubes
- Critical effects observed:
- not specified
- Conclusions:
- The test substance is considered have an NOAEL = 40 mg/kg bw/day; LOAEL = 115 mg/kg bw/day. Therefore the substance should not be classified as STOT RE.
- Executive summary:
Male and female rats were exposed to Na-LAS in the diet daily for 6 months. Diarrhea, suppressed growth, increased cecal weight, and degeneration of renal tubes characterized the highest dose group. Similar but less severe signs were seen in other doses with the exception of the lowest dose of 0.07%, which showed no adverse effects related to exposure to LAS. The resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day, respectively. This represents the lowest LOAEL of any study.
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female rats were exposed to LABS Na in drinking water daily for 9 months.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- C10-14 LAS
sodium salt (CAS #69669-44-9)
average alkyl chain length = C11.7 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Vehicle:
- not specified
- Details on oral exposure:
- LAS was provided daily in drinking water.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- nine months
- Frequency of treatment:
- daily in drinking water
- Dose / conc.:
- 85 mg/kg bw/day (nominal)
- Remarks:
- 0.07%
- Dose / conc.:
- 145 mg/kg bw/day (nominal)
- Remarks:
- 0.2%
- Dose / conc.:
- 430 mg/kg bw/day (nominal)
- Remarks:
- 0.6%
- No. of animals per sex per dose:
- Information as cited in IPCS document. 8-9 animals of each sex per dose group.
- Control animals:
- yes, concurrent no treatment
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain was suppressed in the male 0.6% group.
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Hematological examination revealed no significant change in any of the experimental groups
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- a dose-related decrease in cholesterol level was seen in males. Significant decreases in the activities of glutamate-oxalate transaminase and lactate dehydrogenase were seen in males at 0.2% and a dose-related increase in the activity of gluatamate-oxalate transaminase in females. A significant decrease in renal Na,K-ATPase was seen in the group given 0.2%.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No organ weight changes were observed.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- The intake of LAS was 50 mg/kg bw/day in the male 0.07% group and 120 mg/kg bw/day in the female group. The values for the 0.2% group were 120 and 170 mg/kg bw/day for males and females, respectively.
- Dose descriptor:
- NOAEL
- Effect level:
- 85 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: activities of glutamate-oxalate transaminase and lactate dehydrogenase and renal Na,K-ATPase
- Dose descriptor:
- LOAEL
- Effect level:
- 145 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Significant decreases in the activities of glutamate-oxalate transaminase and lactate dehydrogenase in males. A significant decrease in renal Na,K-ATPase in males and females.
- Critical effects observed:
- not specified
- Conclusions:
- The test substance is established to have an NOAEL = 85 mg/kg bw/day; LOAEL = 145 mg/kg bw/day
- Executive summary:
Male and female rats were exposed to Na-LAS in drinking water daily for 9 months. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase was seen in the 0.2% group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively. The NOAEL represents the highest NOAEL below the lowest LOAEL.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 40 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity - oral
No key repeated dose toxicity study with the target substance is available. Data generated with the supporting substance LABS Na was used to cover this endpoint.
In a repeated dose toxicity study, LABS Na was dosed in male and female Sprague-Dawley rats via oral gavage at dose levels 0, 125, 250 or 500 mg/kg bw/day for 28 days. Body weight gain was suppressed, some serum biochemical measures were different from the controls, and some organ weights were either decreased (spleen, thymus, heart) or increased (liver) in either the male or female high dose groups. No mortalities or histopathological abnormalities were observed. The resultant NOAEL and LOAEL values were 125 and 250 mg/kg bw/day, respectively.
Male and female rats were exposed to LABS Na in the diet daily for 6 months. Diarrhea, suppressed growth, increased cecal weight, and degeneration of renal tubes characterized the highest dose group. Similar but less severe signs were seen in other doses with the exception of the lowest dose of 0.07%, which showed no adverse effects related to exposure to LABS Na. The resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day, respectively. This represents the lowest LOAEL of any study. The substance should not be classified as STOT RE according to the CLP Regulation.
In a supporting, K2 chronic toxicity study, male and female rats were exposed to LABS Na in drinking water daily for 9 months. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase was seen in the 0.2% group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively. The NOAEL represents the highest NOAEL below the lowest LOAEL.
Repeated dose toxicity - inhalation/dermal
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation/dermal route of exposure.
Justification for classification or non-classification
Based on the results above, the substance is not to be classified as STOT RE according to the CLP regulation.
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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