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EC number: 284-902-1 | CAS number: 84989-13-9
- 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
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- 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
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- Endpoint summary
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- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Three-Generation Reproductive Toxicity: NOAEL parental = 350 mg/kg bw/d; NOAEL F1/F2 = 350 mg/kg bw/d; Buehler et al., 1971 (read across from benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. - data on Na-LAS as part of category approach)
Link to relevant study records
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Well documented peer-reviewed publication.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to Section 13.2 for read-across justification document. - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Na-LAS (chain length distribution C10-14) was fed for 84 days to 4 groups of weanling rats (3 dose levels, plus control), each dose consisting of 50 animals each of both sexes (PO-generation). When the P0 generation was 107-112 days old, 20 females from each dose group were mated with 20 males from the same group and maintained together for 17 days. The first litters of each generation (Fla- and F2a-generation) were sacrificed at 21 days of age. Ten days after the final litter was sacrificed, all females were remated with different males from the same group to obtain the F1b generation. From the Flb-generation, 20 males and females of each group were selected at weaning to continue their respective diets and to be used for further reproduction studies. Reproduction studies on the F1b and F2b generations were started when the rats were 80 to 85 days old, and were continued until the F3b generation was weaned.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: (P) weanling; (F1) 21 days
- Weight at study initiation: (P) Males: average 59.4-59.9 g; Females: average 57.0-57.3 g; (F1) Males: group weight 183.5-214.2 g; Females: group weight 157.8-193.2 g
- Housing: individual wire bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 76 +/- 3
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs - Route of administration:
- oral: feed
- Vehicle:
- other: LAS was administered in feed (Purina Laboratory Meal) - no documentation of dilution prior to addition to meal
- Details on mating procedure:
- premating exposure period 84 days
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 years ( 3 generations)
- Frequency of treatment:
- continuous in feed
- Details on study schedule:
- - F1 parental animals not mated until 80-85 days old
- Selection of parents from F1 generation when pups were 21 days of age.
- Age at mating of the mated animals in the study: 107-112 days old - Dose / conc.:
- 14 mg/kg bw/day
- Remarks:
- Basis:
actual ingested - Dose / conc.:
- 70 mg/kg bw/day
- Remarks:
- Basis:
actual ingested - Dose / conc.:
- 350 mg/kg bw/day
- Remarks:
- Basis:
actual ingested - No. of animals per sex per dose:
- 50 males and 50 females per group.
- Control animals:
- yes, concurrent no treatment
- Litter observations:
- 50 males and 50 females per group.
- Postmortem examinations (parental animals):
- Necropsy, body weight, organ to body weight ratios, routine hematology and histology.
- Postmortem examinations (offspring):
- Necropsy, body weight, organ to body weight ratios, routine hematology and histology.
- Reproductive indices:
- fertility, gestation, parturition, neonatal viability, lactation, and post-weaning growth
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- no effects to body weight were noted in the initial twelve weeks
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- no effects to body weight were noted in the initial twelve weeks
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- Test substance intake: no effects to average food consumption were noted in the initial twelve weeks
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 0.5 %
- Critical effects observed:
- no
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: 0.5 %
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 0.5 %
- Reproductive effects observed:
- no
- Conclusions:
- No significant effects on reproduction were observed at the highest concentration tested.
- Executive summary:
Na-LAS was fed for 84 days to 4 groups of weanling rats for two years (three generations). No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw (0.5%).
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to Section 13.2 for read-across justification document. - Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 0.5 %
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 0.5 %
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 0.5 %
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- No significant effects on reproduction were observed at the highest concentration tested.
- Executive summary:
In a one-to-one read-across approach, the substance benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. (data on LAS as part of category approach) is considered appropriate for direct read-across (one-to-one) to benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts (target substance) for the endpoint toxicity to reproduction. Na-LAS was fed for 84 days to 4 groups of weanling rats for two years (three generations). No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw (0.5%).
In conclusion, The test substance has no adverse effects on reproduction. A full justification for the read-across approach is presented in IUCLID Section 13.2.
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 350 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The database consists of a single high quality studies that exceeds the standard tier of data requirements for the registered tonnage band. All studies (key and supporting) are of high quality.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a one-to-one read-across approach, the substance benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. (data on LAS as part of category approach) is considered appropriate for direct read-across (one-to-one) to benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts (target substance) for the endpoint toxicity to reproduction. Na-LAS was fed for 84 days to 4 groups of weanling rats for two years (three generations). No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw (0.5%).
In conclusion, The test substance has no adverse effects on reproduction. A full justification for the read-across approach is presented in IUCLID Section 13.2.
The key study (Buehler et al., 1971) examined the potential reproductive toxicity of Na-LAS (read across). Na-LAS was given in the feed at doses of 0.02, 0.1, and 0.5% (14, 70, and 350 mg/kg bw d) for 84 days to four groups of weanling rats and evaluated for two years (three generations). Each dose consisting of 50 animals each of both sexes (P0-generation). When the P0-generation was 107-112 days old, 20 females from each dose group were mated with 20 males from the same group and maintained together for 17 days. The first litters of each generation (Fla- and F2a-generation) were sacrificed at 21 days of age. Ten days after the final litter was sacrificed, all females were remated with different males from the same group to obtain the F1b-generation. From the Flb-generation, 20 males and females of each group were selected at weaning to continue their respective diets and to be used for further reproduction studies. Reproduction studies on the F1band F2b-generations were started when the rats were 80 to 85 days old, and were continued until the F3b-generation was weaned. All rats sacrificed at weaning were normal with respect to growth, organ to body weight ratios, gross pathology, and histology, and did not vary from controls. There were a number of statistically significant hematologic values, though these differences were small and did not indicate a trend or pattern. Overall, no significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was the highest dose tested, i.e., 350 mg/kg bw (0.5%).
Effects on developmental toxicity
Description of key information
Maternal NOAEL = 300 mg/kg bw/d, Developmental NOAEL = 600 mg/kg bw/d
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Well documented peer-reviewed journal article
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to Section 13.2 for read-across justification document. - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Twenty female rats were administered 0.2, 2.0, 300 or 600 mg/kg bw of LAS by gavage at days 6-15 of gestation. All animals were sacrificed on day 20 of pregnancy.
- GLP compliance:
- no
- Remarks:
- Study pre-dated GLP
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CD
- Details on test animals or test system and environmental conditions:
- Source: Charles River Breeding Laboratories, Wilmingoton, Mass., USA.
Rats were housed 5 per cage in opaque plastic cages, and maintained under environmental conditions of 20 +/- 1°C and 50 +/- 5% RH. All animals were allowed free access to drinking water and food (Spratt’s Laboratory Diet No. 1). - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- For administration each material was prepared daily as a series of graded aqueous solutions so that within each study animals in all groups were dosed orally by intragastric intubation at a standard volume. Control animals were dosed with water.
- Duration of treatment / exposure:
- days 6 - 15 of pregnancy
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0.2 mg/kg bw/day
- Dose / conc.:
- 2 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 600 mg/kg bw/day
- No. of animals per sex per dose:
- 20 female rats per dose
- Control animals:
- yes, concurrent no treatment
- Maternal examinations:
- The day of mating as judged by the detection of the vaginal plug in rats was considered day 0; dosing commenced on day 6 and continued daily up to and including day 15.
Throughout the experiment all animals were observed daily for signs of malreaction and were weighed regularly throughout gestation. All animals that died, and survivors at termination, were dissected and examined for macroscopic changes.
At termination (days 20) rats were euthanised by carbon dioxide euthanasia. The uteri were immediately dissected and the contents examined to determine the numbers of {a) implantations, (b) viable young, (c) embryonic deaths (abortion or resorption sites). - Ovaries and uterine content:
- Ovaries were examined and the number of corpora lutea counted.
- Fetal examinations:
- Viable young were weighed and carefully examined for external abnormalities. Following weighing and examination for external malformations, one third of the foetuses were fixed in Bouin's fluid for subsequent free hand sectioning to detect visceral anomalies, and the remaining two thirds fixed in alcohol for subsequent dissection and examination followed by clearing, alizarin staining and skeletal examination.
- Statistics:
- In assessing results group mean values were calculated from the individual litter data in two ways. Mean A: includes all surviving animals showing evidence of implantation, including those with total litter loss. Mean B: includes only animals bearing viable young at termination.
Mean B has more meaning when only the occasional animal shows total litter loss, Mean A provides a better index when several animals show total litter loss.
Differences in mean values were statistically analysed by non-parametric methods (Wilcoxon test) since litter values rarely, if ever, follow a normal (Gaussian) distribution; in all analyses the litter was considered as the basic sample unit. - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Toxic effects were generally associated with a principal disturbance of the gastrointestinal tract.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- a single mortality was observed at 600 mg/kg bw/d. No evidence was offered as to whether this was related to test item dosing or an isolated incident.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant body weight gain reduction was seen at 600 mg/kg bw/d.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Body weight gain was retarded in the highest dose group from the start of dosing and showed partial recovery toward the end of the dosing period. One animal died in this group but it could not be conclusively related to treatment. The toxic effects were associated with disturbance of the gastrointestinal tract.
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- No differences were observed among dose groups and the control group with respect to number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, pre- and post implantation embryonic loss, major malformations, minor visceral or embryonic loss, major malformations, minor visceral or skeletal anomalies or incidence of pups with extra ribs.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- Based on the results of the study, the maternal NOAEL = 300 mg/kg bw/d and the developmental NOAEL = 600 mg/kg bw/d.
- Executive summary:
Pregnant female rats (20 animals per group) were exposed to LAS via gavage on days 6 -15 of gestation.
Maternal toxicity:
Body weight gain was retarded in the highest dose group from the start of dosing and showed partial recovery toward the end of the dosing period. One animal died in this group but it could not be conclusively related to treatment. The toxic effects were associated with disturbance of the gastrointestinal tract. Pregnancy rate was comparable at all dosages.
Teratogenicity:
No differences were observed among dose groups and the control group with respect to number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, pre- and post implantation embryonic loss, major malformations, minor visceral or embryonic loss, major malformations, minor visceral or skeletal anomalies or incidence of pups with extra ribs.
Based on the results of the study, the maternal NOAEL = 300 mg/kg bw/d and the developmental NOAEL = 600 mg/kg bw/d.
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to Section 13.2 for read-across justification document. - Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Abnormalities:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- Based on the results of the study, the maternal NOAEL = 300 mg/kg bw/d and the developmental NOAEL = 600 mg/kg bw/d.
- Executive summary:
In a one-to-one read-across approach, the substance benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. (data on LAS as part of category approach) is considered appropriate for direct read-across (one-to-one) to benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts (target substance) for the endpoint developmental toxicity.
Pregnant female rats (20 animals per group) were exposed to LAS via gavage on days 6 -15 of gestation.
Maternal toxicity:Body weight gain was retarded in the highest dose group from the start of dosing and showed partial recovery toward the end of the dosing period. One animal died in this group but it could not be conclusively related to treatment. The toxic effects were associated with disturbance of the gastrointestinal tract. Pregnancy rate was comparable at all dosages.
Teratogenicity:No differences were observed among dose groups and the control group with respect to number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, pre- and post implantation embryonic loss, major malformations, minor visceral or embryonic loss, major malformations, minor visceral or skeletal anomalies or incidence of pups with extra ribs.
Based on the results of the study, the maternal NOAEL = 300 mg/kg bw/d and the developmental NOAEL = 600 mg/kg bw/d.
A full justification for the read-across approach is presented in IUCLID Section 13.2.
Referenceopen allclose all
Summary of adult performance
Observation | Number of animals at dosage | ||||
mg/kg bw/d | 0 | 0.2 | 2 | 300 | 600 |
Mated | 20 | 20 | 20 | 20 | 20 |
Died | 0 | 0 | 0 | 0 | 1 |
Non-pregnant | 5 | 5 | 2 | 4 | 3 |
Total litter loss | 0 | 1 | 0 | 0 | 0 |
With viable young | 15 | 14 | 18 | 16 | 16 |
Bodyweight change | - | - | - | - | Retarded weight gain |
Group mean incidence of major malformations and minor anomalies
Dosage | Number of Young | Incidence of pups with extra ribs * | |||||||||
Major malformations | Minor anomalies | ||||||||||
Examined | Affected | Gross or visceral | Skeletal | Mean % | |||||||
(mg/kg) | Total number | Mean % | Examined | Total Number Affected | Mean % Affected | Examined | Total Number Affected | Mean % Affected | Cervical | Lumbar | |
0 | 149 | 0 | 0 | 33 | 1 | 2.2 | 116 | 2 | 2.0 | 18.6 | |
0.2 | 137 | 0 | 0 | 26 | 0 | 0 | 111 | 2 | 1.7 | 33.1 |
|
2 | 147 | 0 | 0 | 22 | 0 | 0 | 125 | 5 | 3.5 | 21.3 | |
300 | 153 | 1 | 0.6 | 30 | 0 | 0 | 122 | 4 | 3.6 | 12.9 | |
600 (M) | 166 | 0 | 0 | 34 | 1 | 6.7 | 132 | 2 | 1.8 | 15.3 |
* Young showing major malformations excluded
(M) denotes minor maternal toxicity
Group Litter Data
Embryonic Loss (%) | |||||||||
Dosage (mg/kg) | Number of Litters | Litter Size and Viable Young | Embryonic Deaths | Implantations | Corpora Lutea | Pre-Implantation | Post-Implantation | Litter Weight (g) | Foetal Weight (g) |
0 | 15 | 9.9 | 0.3 | 10.3 | 12.5 | 18.1 | 2.8 | 36.15 | 3.66 |
0.2 | 14 | 9.8 | 0.6 | 10.4 | 12.8 | 18.4 | 6.1 | 37.14 | 3.84 (a) |
2 | 18 | 8.2 | 0.6 | 8.8 | 13.9 | 36.9 | 5.9 | 31.62 | 3.94 (b) |
300 | 16 | 9.6 | 0.4 | 10.0 | 12.4 | 15.6 | 3.6 | 35.72 | 3.78 |
600 (M) | 16 | 10.4 | 0.4 | 10.8 | 13.9 | 20.3 | 3.1 | 37.49 | 3.64 |
Differences from controls statistically significant at Wilcoxon test (a) P < 0.05; (b) P < 0.001
(M) denotes minor maternal toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The database consists of high quality studies on the rat and mouse, that exceeds the standard data requirements for the registered tonnage band. All studies (key and supporting) are of high quality.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a one-to-one read-across approach, the substance benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. (data on LAS as part of category approach) is considered appropriate for direct read-across (one-to-one) to benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts (target substance) for the endpoint developmental toxicity.
Pregnant female rats (20 animals per group) were exposed to LAS via gavage on days 6 -15 of gestation.
Maternal toxicity:Body weight gain was retarded in the highest dose group from the start of dosing and showed partial recovery toward the end of the dosing period. One animal died in this group but it could not be conclusively related to treatment. The toxic effects were associated with disturbance of the gastrointestinal tract. Pregnancy rate was comparable at all dosages.
Teratogenicity:
No differences were observed among dose groups and the control group with respect to number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, pre- and post implantation embryonic loss, major malformations, minor visceral or embryonic loss, major malformations, minor visceral or skeletal anomalies or incidence of pups with extra ribs.
Based on the results of the study, the maternal NOAEL = 300 mg/kg bw/d and the developmental NOAEL = 600 mg/kg bw/d.
A full justification for the read-across approach is presented in IUCLID Section 13.2.
Mode of Action Analysis / Human Relevance Framework
Not applicable, no reproductive or developmental toxicity was observed in any of the presented studies.
Justification for classification or non-classification
The substance does not meet the criteria for classification in accordance with Regulation (EC) No 1272/2008.
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