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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 246-680-4 | CAS number: 25155-30-0
- 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
Oral repeated dose toxicity
Repeated oral dosing of dodecylbenzenesulfonic acid (as a read across for Sodium dodecylbenzenesulfonate ) resulted in soft feces, and squamous cell hyperplasia of stomach in both sexes, and liquid feces and soled perineal region, a decrease in body weight and food consumption, forestomach erosion/ulcer in males at 400 mg/kg bw/day, and squamous cell hyperplasia of stomach in both sexes at 200 mg/kg bw/day. Based on results, all findings were completely or partially reversed during the 15 days recovery period. The target organ for oral dosing of dodecylbenzenesulfonic acid was considered as stomach.
The NOAEL and the LOAEL for repeated toxicity of Sodium dodecylbenzenesulfonate was considered to be 100 mg/kg bw/day and 200 mg/kg bw/day in both sexes, respectively.
Dermal repeated dose toxicity
LAS (as a read across) was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day).
Histological examinations of the application site revealed severe necrosis of the region from the epidermis cuticle to the upper layer of the dermis, severe infiltration of leukocytes in the necrotic site, and diffuse inflammatory cell infiltration of all layers of the corium. The effects on body weight are to be considered related to the LAS irritation.
The LOAEL for these effects is 286 mg/kg bw/day, the lower dose tested.
The NOAEL for these effects is<286 mg/kg bw/day.
Inhalation repeated dose toxicity
There are no Inhalation repeated studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
100 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat - 4.35 mg/m3
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:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Dodecylbenzene sulfonic acids (CAS# 27176-87-0 , EC Number; 248-289-4) ) is a very close analogue of Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0, EC Number; 246-680-4) ) and the dissociated acid it readily dissociates in water and release the dodecylbenzene sulfonic anion in solution.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 1) Test animals- Supplier: Orient Bio Co. Ltd. 143-1, Sangdaewon-dong, Jungwon-ku, Sungnam, Gyunggi-do, 462-120 Korea- Age at study initiation: 7-week-old animals for male and female- No. of animals at receipt: 57 for male and female- Body weights at study initiation: 212.5 – 243.8 g for males and 147.6 -168.6 g for females- Age at the first day of treatment: 8 weeks for male and female- Body weight range at the first day of treatment: 274.2∼311.1 g for males and 175.7∼213.4 g for females- All animals were visually examined on acquisition. Only the animals remained in good physical condition during the 6-day acclimatization in the animal room were selected for the test.
2) Environmental condition- Temperature 23 +/- 3 deg C, relative humidity of 50 +/- 10%; ventilation of 10 to 20 times/hours; light/dark cycle 12 h/12 h- All animals used in this study were cared for in accordance with the principles outlined in the "Guide for the Care and Use of Laboratory Animals", a NIH publication.
3) Monitoring- Room temperature was generally in the range 20 ~ 26 deg C, relative humidity was generally in the range 40 ~ 60%. No significant deviations, which can affect the experiment, were observed.
4) Housing and identification of animals- Equal or less than five for the quarantine and acclimatization- Equal or less than two for the pre-mating, treatment and recovery period5) Diet, water and bedding material- Pelleted maintenance diet and tap water ad libitum; no contaminants (analysed) - Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test article of the highest dose group was mixed with water for injection, and the low dose group's test article was prepared by dilution of that of the highest dose group. The test article solutions were prepared once a day before completion of the analytical method validation, and after completion the test article was formulated over once a week.
- Duration of treatment / exposure:
- From 2 weeks before mating to the end of the mating period for male (at least 28 days)From 2 weeks before mating to day 4 of lactation including the mating and gestation periods for female- Post exposure period: 15 days in both sexes
- Frequency of treatment:
- Once daily
- Remarks:
- Doses / Concentrations:
0, 100, 200, and 400 mg/kg bw/day (Dosing volume 10ml/kg/day)
Basis:
nominal in diet - No. of animals per sex per dose:
- 10 males and females for 100 and 200 mg/kg bw/day and 16 males and females for 400 mg/kg bw/day (10 was for test group and 6 was for recovery group), 16 males and females for vehicle control (10 was for test group and 6 was for recovery group)
- Control animals:
- yes
- Details on study design:
- - Dose levels determined in a pilot toxicity study of dodecylbenzenesulfonic acid in rats- Constant dosage volume of 10 mL/kg bw/day: calculated with Path/Tox system according to the basis of recently measured body weight.- Dosing of both sexes was begun at 2 weeks prior to mating. Dosing was continued in both sexes during the mating period. Males were dosed after the mating period at least until the minimum total dosing period of 28 days had been completed. Daily dosing of the parental females was continued throughout pregnancy and at least up to day 4 post-partum
- Statistics:
- - Body weights, food consumption, organ weights, and clinical pathology : means the standard deviation of each mean. - Bartlett's test : analyzing for homogeneity of variance- Dunnett's t test : analyzing for the significance of inter-group differences- Analysis of Variance : analyzing for homogeneous data- Kruskal-Wallis test : analyzing for Heterogeneous data- Dunn's Rank Sum test : analyzing for the significance of inter-group differences between the control and treated groups- F test : analyzing the data of recovery groups for homogeneity of variance- Dunnett's t test : analyzing for homogeneous data- Dunn's Rank Sum test : analyzing for the significance of inter-group differences- t test : analyzing for Heterogeneous data- Kruskal-Wallis test : analyzing for the significance of inter-group differences between the control and treated group-Statistical analyses were performed by comparing the different dose groups with the vehicle control group using Path/Tox System. - p<0.05 or p<0.01
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- -Clinical signs: Treatment-related clinical signs such as salivation and soft feces were observed in all males of the 400 mg/kg bw/day group during the premating and mating periods. Soiled perineal and liquid feces were observed in 2 males of 400 mg/kg bw/day group during the premating. Salivation and soft feces were observed in 9 and 8 females during the premating and in 8 and 5 during the mating period in the 400 mg/kg bw/day group, respectively. Thin appearance, salivation, staining around mouth, soiled perineal region and soft feces were observed in 1, 10, 1, 1 and 4 females during the gestation period in the 400 mg/kg group, respectively. Thin appearance and salivation were observed in 1 and 10 animals in the 400 mg/kg bw/day group during the lactation period, respectively.
- Body weights and food consumption: In males, a statistically significant decrease was observed on days 8 and 14 of premating. In females, there was no statistically significant changes except a decrease on day 20 of gestation at 400 mg/kg bw/day. In males, a statistically significant decrease in food consumption was observed in the 400 mg/kg bw/day group on days 2 and 9 of the premating, and in females it was observed on day 2 of premating and day 8 of gestation.
- Neurobehavioral evaluation: No treatment-related changes were observed in any of the treatment group.- Urinalysis for males: There were no treatment-related changes for males.
- Hematological test : In hematology test, activated partial thromboplastin time (APTT) was statistically significantly decreased in male of the 400 mg/kg bw/day group. No treatment-related changes were observed in females. In recovery group, a statically significant decrease in RBC count (RBC) was observed in males of the 400 mg/kg bw/day group and an increase in mean corpuscular hemoglobin (MCH) was observed in females.
- Biochemical test: In serum biochemistry test, a statistically significant increase in A/G ratio andalanine aminotransferase (ALT) was observed in males of the 400 mg/kg bw/day group. In females, a statistically significant decrease in blood urine nitrogen (BUN) observed in all treatment groups and an decrease in albumin (ALB) was also observed in the 400 mg/kg bw/day group. In recovery group, a statistically significant decrease in ALT and increase in ALP were observed in females of the 400 mg/kg bw/day group.
- Gross findings: There were no treatment-related changes for all animals
- Organ weights: In males, no a statistically significant changes were observed in any of the treatment groups. In females, a statistically significant increase in absolute weight of ovaries was observed in the 200 mg/kg bw/day group, and a decrease in absolute weight of salivary gland and heart was observed in the 400 mg/kg bw/day groups. The mean weight of ovaries for main group was 0.108 g in compared with vehicle control of 0.093 g and the mean weight of salivary glands for main group was 0.462 g in compared with vehicle control of 0.532 g. Also, the mean weight of heart for main group was 0.816 g in compared with vehicle control of 0.955 g. In recovery groups, a significant decrease in liver and kidney was observed in males the 400 mg/kg bw/day group. No significant differences were observed between vehicle control and test group for organ weights in females.
- Histopathological findings: Squamous cell hyperplasia in stomach was observed in males and females at 200 and 400 mg/kg bw/day. Two cases of minimal forestomach erosion/ulcer were also observed in males at 400 mg/kg bw/day. - Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- Critical effects observed:
- not specified
- Conclusions:
- Oral administration of dodecylbenzenesulfonic acid to rats resulted in soft feces, and squamous cell hyperplasia of stomach in both sexes at 400mg/kg bw/day, and liquid feces and soled perineal region, a decrease in body weight and food consumption in males at 400 mg/kg bw/day. In hematology examination, squamous cell hyperplasia of stomach was observed in both sexes at 200 mg/kg bw/day and forestomach erosion/ulcer was observed in males at 400mg/kg bw/day. Based on these effects the NOAEL value was 100 mg/kg bw/day for male and female rats and the LOAEL value was 200 mg/kg bw/day for male and female rats. From these results, the target organ for oral dosing of dodecylbenzenesulfonic acid was considered to be the stomach.
- Executive summary:
Repeated oral dosing of dodecylbenzenesulfonic acid resulted in soft feces, and squamous cell hyperplasia of stomach in both sexes, and liquid feces and soled perineal region, a decrease in body weight and food consumption, forestomach erosion/ulcer in males at 400 mg/kgbw/day, and squamous cell hyperplasia of stomach in both sexes at 200 mg/kgbw/day.Also,activated partial thromboplastin time (APTT) was statistically significantly decreased in male of the 400 mg/kg bw/day group. Inserum biochemistry test, a statistically significant increase in A/G ratio and alanine aminotransferase (ALT) was observed in males of the 400 mg/kg bw/day group.As a result of organ weight test, no a statistically significant changes were observed in any of the treatment groups in males. A statistically significant increase in absolute weight of ovaries was observed in the 200 mg/kg bw/day group, and a decrease in absolute weight of salivary gland and heart was observed in the 400 mg/kg bw/day groups.
Based on results, all findings were completely or partially reversed during the15daysrecovery period. The target organ for oral dosing of dodecylbenzenesulfonic acid was considered as stomach. The NOAEL and the LOAEL for repeated toxicity of dodecylbenzenesulfonic acid was considered to be 100 mg/kg bw/day and 200 mg/kg bw/day in both sexes, respectively.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 4.35 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Inhalation exposure:
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
100 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat 4.35 mg/m3
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 4.35 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Inhalation exposure:
There are no Inhalation Repeated studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
100 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat 4.35 mg/m3
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- LAS was applied to the backs of the rats. On the 16th day of the experiment, skin at the application site and the tissues of the tongue and oral mucosa (to examine the effects of licking) of the rats that received 30% were examined histologically
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Type of coverage:
- occlusive
- Vehicle:
- other: distilled water
- Details on exposure:
- LAS was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day).
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 15 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
286 and 427 mg/kg bw day
Basis:
nominal per unit body weight - Control animals:
- yes
- Details on study design:
- LAS was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day). On the 16th day of the experiment, the animals were assessed. Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site.
- Sacrifice and pathology:
- On the 16th day of the experiment, skin at the application site and the tissues of the tongue and oral mucosa (to examine the effects of licking) of the rats that received 30% were examined histologically
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site.
Histological examinations of the application site revealed severe necrosis of the region from the epidermis cuticle to the upper layer of the dermis, severe infiltration of leukocytes in the necrotic site, and diffuse inflammatory cell infiltration of all layers of the corium.
The effects on body weight are to be considered related to the LAS irritation. - Dose descriptor:
- NOAEL
- Effect level:
- < 286 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Dose descriptor:
- LOAEL
- Effect level:
- 286 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Critical effects observed:
- not specified
- Conclusions:
- The LOAEL for body weight effects is 286 mg/kg bw/day, the lower dose tested.
The NOAEL for body weight effects is <286 mg/kg bw/day. - Executive summary:
LAS was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day). On the 16thday of the experiment, the animals were assessed. Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site. Histological examinations of the application site revealed severe necrosis of the region from the epidermis cuticle to the upper layer of the dermis, severe infiltration of leukocytes in the necrotic site, and diffuse inflammatory cell infiltration of all layers of the corium. The effects on body weight are to be considered related to the LAS irritation.
The LOAEL for these effects is 286 mg/kg bw/day, the lower dose tested.
The NOAEL for these effects is<286 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 286 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- LAS was applied to the backs of the rats. On the 16th day of the experiment, skin at the application site and the tissues of the tongue and oral mucosa (to examine the effects of licking) of the rats that received 30% were examined histologically
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Type of coverage:
- occlusive
- Vehicle:
- other: distilled water
- Details on exposure:
- LAS was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day).
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 15 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
286 and 427 mg/kg bw day
Basis:
nominal per unit body weight - Control animals:
- yes
- Details on study design:
- LAS was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day). On the 16th day of the experiment, the animals were assessed. Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site.
- Sacrifice and pathology:
- On the 16th day of the experiment, skin at the application site and the tissues of the tongue and oral mucosa (to examine the effects of licking) of the rats that received 30% were examined histologically
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site.
Histological examinations of the application site revealed severe necrosis of the region from the epidermis cuticle to the upper layer of the dermis, severe infiltration of leukocytes in the necrotic site, and diffuse inflammatory cell infiltration of all layers of the corium.
The effects on body weight are to be considered related to the LAS irritation. - Dose descriptor:
- NOAEL
- Effect level:
- < 286 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Dose descriptor:
- LOAEL
- Effect level:
- 286 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Critical effects observed:
- not specified
- Conclusions:
- The LOAEL for body weight effects is 286 mg/kg bw/day, the lower dose tested.
The NOAEL for body weight effects is <286 mg/kg bw/day. - Executive summary:
LAS was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day). On the 16thday of the experiment, the animals were assessed. Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site. Histological examinations of the application site revealed severe necrosis of the region from the epidermis cuticle to the upper layer of the dermis, severe infiltration of leukocytes in the necrotic site, and diffuse inflammatory cell infiltration of all layers of the corium. The effects on body weight are to be considered related to the LAS irritation.
The LOAEL for these effects is 286 mg/kg bw/day, the lower dose tested.
The NOAEL for these effects is<286 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1.6 mg/cm²
- Study duration:
- subacute
- Species:
- rat
Additional information
Oral repeated dose toxicity
Oral administration ofdodecylbenzenesulfonic acid (as a read across for Sodium dodecylbenzenesulfonate) to rats resulted in soft feces, and squamous cell hyperplasia of stomach in both sexes at 400 mg/kg bw/day, and liquid feces and soled perineal region, a decrease in body weight and food consumption in males at 400 mg/kg bw/day. In hematology examination, squamous cell hyperplasia of stomach was observed in both sexes at 200 mg/kg bw/day and forestomach erosion/ulcer was observed in males at 400mg/kg bw/day. Based on these effects the NOAEL value was 100 mg/kg bw/day for male and female rats and the LOAEL value was 200 mg/kg bw/day for male and female rats.
From these results, the target organ for oral dosing of dodecylbenzenesulfonic acid (as a read across for Sodium dodecylbenzenesulfonate) was considered to be the stomach.
NOAEL -100 mg/kg bw/day for male and female rats.
Dermal repeated dose toxicity
LAS (as a read across) was applied for 15 days to the backs of male rats, at daily doses of 0.5 g of solutions at 20 and 30% (about 286 and 427 mg/kg bw/day). On the 16thday of the experiment, the animals were assessed. Body weight gain was suppressed in the 20% group (286 mg/kg bw/day) and the body weight was decreased in the 30% group (427 mg/kg bw/day). An infiltrating, yellowish-reddish brown crust was observed after 2-3 days in the lower dose group, and after 1-2 days in the high dose group. After 4-6 days the crust was abraded and erosion occurred at the abraded site. Histological examinations of the application site revealed severe necrosis of the region from the epidermis cuticle to the upper layer of the dermis, severe infiltration of leukocytes in the necrotic site, and diffuse inflammatory cell infiltration of all layers of the corium. The effects on body weight are to be considered related to the LAS irritation.
The LOAEL for these effects is 286 mg/kg bw/day, the lower dose tested.
The NOAELfor these effects is<286mg/kg bw/day.
Inhalation repeated dose toxicity
There are no Inhalation repeated studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
100 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat - 4.35 mg/m3
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be
NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)
NOAELtest* 0.25/44.5= NOAELmodified
The highest dose not causing irritation/corrosion was 286 mg/kg bw in dermal toxicity study in rats of Sadai, M. and Mizuno, N. 1972.
the modified dose descriptor would be
NOAELmodified =286 mg/kg*0.25 kg/44.5cm2=1.6 mg/cm2
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach; other: all gross lesions and masses
Repeated dose toxicity: inhalation - systemic effects (target organ) digestive: stomach; other: all gross lesions and masses
Repeated dose toxicity: dermal - systemic effects (target organ) other: all gross lesions and masses
Justification for classification or non-classification
Based on the hazard assessment of Sodium dodecylbenzenesulfonate in section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Repeated dose toxicity R33 Danger of cumulative effects. T; R48/23 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation. T; R48/23/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. T; R48/23/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/23/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin. T; R48/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. T; R48/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure if swallowed. Xn; R48/20 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation. Xn; R48/20/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. Xn; R48/20/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. Xn; R48/20/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed. Xn; R48/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin. Xn; R48/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. Xn; R48/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure if swallowed.
|
CLP |
Repeated dose toxicity STOT Rep. Exp. 1 STOT Rep. Exp. 2 H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. |
It is concluded that the substance Sodium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for Repeated dose toxicity
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.