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EC number: 701-368-1 | CAS number: 1962138-75-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The purpose of this study was to evaluate the teratogenic potential of linear alkylbenzene sulphonate (LAS) in rats. Twenty female rats/dose were divided into 5 groups and administered 0 (water), 0.2, 2.0, 300 and 600 mg/kg bw/day of test substance by oral gavage from day 6 to 15 of gestation. Throughout experiment animals were observed daily for signs of malreaction and weighed regularly. After euthanasia on day 20, their uterine content was examined for number of implantations, viable young and embryonic deaths along with ovaries, number of corpora lutea and viable pups. Body weight, incidents of external malformation, visceral and skeletal anomalies were also recorded in pups. Non parametric methods were used for statistical analysis and on the basis of adverse effects, NOAEL value was derived for maternal toxicity and teratogenicity.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
- EC Number:
- 270-115-0
- EC Name:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
- Cas Number:
- 68411-30-3
- Molecular formula:
- LAS is the sodium salt of linear alkylbenzene sulfonic acid with alkyl carbon chain lengths ranging from C10 to C13 and averaging 11.6. The primary structure is a C10 to C13 linear alkyl chain with a para-substituted benzene sulfonic acid sodium salt group attached at any of the secondary alkyl carbon positions
- IUPAC Name:
- sodium 4-undecylbenzenesulfonate
- Details on test material:
- -Name of test material (as cited in article): LAS
-Supplied by Lion Fat & Oil Co., Tokyo, Japan.
No further details were provided in article
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD rats
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Mass., U.S.A. and St-Aubin-les-Elbeuf, France.
- Housing: Female rats (5 per cage) were housed in opaque plastic cages.
- Diet: Spratt’s Laboratory Diet No. 1, ad libitum.
- Drinking water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1°C
- Humidity: 50 ± 5 % RH
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- - Preparation of dosing solutions: Doses were prepared on daily basis as series of graded aqueous solutions for oral dosing.
- Administration of dosage: Standard volume of doses was administered orally by gastric intubation. Control animals were dosed with water.
- Duration of dosage: Doses were commenced on day 6 after detection of vaginal plug in rats and continued daily up to and including day 15 of gestation. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Mating was confirmed by the detection of vaginal plug in rats.
- Duration of treatment / exposure:
- Animals were dosed for 10 days [from Day 6 (after detection of vaginal plug) to Day 15].
- Frequency of treatment:
- daily from day 6 after detection of the vaginal plug to till day 15
- Duration of test:
- 21 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- (control)
- 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
- Details on study design:
- - Dose selection rationale: Two doses formed the basis for safety evaluation (0.2 and 2.0 mg/kg bw/day) because the likely maximum human intake of detergent from ordinary kitchen use has been estimated at 0.14 mg/kg bw/day, thus providing factors of 1-2 times the human exposure level. Two further doses (300 and 600 mg/kg bw/day) were also investigated based on previous toxicity data suggesting that these would impair maternal economy and result in obvious adverse effects.
Examinations
- Maternal examinations:
- 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.
- Ovaries and uterine content:
- After euthanasia, uteri were dissected and examined to determine the number of:
a) Implants
b) Viable young
c) Embryonic deaths (abortion/resorption sites)
Ovaries were examined and number of corpora lutea were also recorded. - Fetal examinations:
- After weighing, fetus were examined for external malformations, visceral anomalies by free and sectioning and skeletal examination was performed by alizarin staining.
- Statistics:
- Differences in mean values were statistically analyzed by non-parametric method i.e. Wilcoxon test.
- Historical control data:
- In CD rats, percentage of major malformations, minor visceral anomalies and minor skeletal anomalies were recorded as 0.41%, 2.02% and 2.35%, respectively in 51349 examined fetuses.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Toxic effects were generally associated with the gastrointestinal tract disturbances.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Single mortality was observed at 600 mg/kg bw/day.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Retarded weight gain was observed on 600 mg/kg bw/day.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- Retarded weight gain was observed on 600 mg/kg bw/day. No other significant maternal toxicity was observed at all doses when compared to the control group. Mating index was also comparable across all doses when compared to the control group.
Maternal developmental toxicity
- 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:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Body weight: Moderate maternal toxicity was observed in 600 mg/kg bw/day on the basis of retarded weight gain.
Litter loss: Only single litter was lost at 0.2 mg/kg bw/day but not significant as no dose response relationship was followed.
Pre-implantation embryonic losses were 18.1%, 23.2%, 36.9%, 15.6% and 20.3% at 0, 0.2, 2, 300 and 600 mg/kg bw/day, respectively.
Post-implantation embryonic losses were 2.8%, 12.4%, 5.9%, 3.6% and 3.1% at 0, 0.2, 2, 300 and 600 mg/kg bw/day, respectively.
Embryonic deaths were 0.3, 0.7, 0.6, 0.4 and 0.4 at 0, 0.2, 2, 300 and 600 mg/kg bw/day, respectively.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: mortality and retarded weight gain at 600 mg/kg bw/day
Maternal abnormalities
- Abnormalities:
- not examined
Results (fetuses)
- 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:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- EMBRYO TOXICITY
Fetal weights: Although the fetal weights differed significantly at 0.2 and 2 mg/kg bw/day, these changes does not represent an adverse change because there was no consistent dose relationship and were invariably due to higher mean pub weight in the test group.
Fetal loss: No test substance related effect or statistically significant differences were observed.
Litter size and weight: Litter size and weights were comparable across all doses when compared to the control group.
MALFORMATIONS:
No test substance related or statistically differences in the incidence of major malformations observed even a maternally toxic dosage but minor visceral anomalies were increased at 600 mg/kg bw/day (not significant statistically) but same incident was also observed in control group.
DEVELOPMENTAL VARIATIONS:
Incidences of skeletal abnormalities were comparable across all doses when compared to the control group.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: marginal retardation of sternebral ossification at the highest dose
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 600 mg/kg bw/day (nominal)
- Treatment related:
- not specified
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
Any other information on results incl. tables
Formula for calculation of mating index:
Mating index: (number of confirmed mating/ number of animals cohabitated) X 100
Table 1: Mating index of the maternal animals (Palmer et.al., 1975)
Dose | Number of confirmed mating |
Number of animals cohabitated |
Mating index % |
0 | 15 | 20 | 75 |
0.2 | 15 | 20 | 75 |
2 | 18 | 20 | 90 |
300 | 16 | 20 | 80 |
600 | 16 | 19 | 84 |
Table 2: Summary of adult performance (Palmer et.al., 1975)
Observations | Number of animals at dosage (mg/kg bw/day) | ||||
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 |
Body weight change | - | - | - | - | retarded gain |
Table 3: Group mean litter data (Palmer et.al., 1975)
Dosage (mg/kg bw/day) |
Number of litters | Litter size viable young | Embryogenic deaths | Implantations | Corpora lutea | Embryonic loss % | Litter weight (g) | Fetal weight (g) | |
Pre-implantation | Post-implantation | ||||||||
0 | 15 (A & B) | 9.9 | 0.3 | 10.3 | 12.5 | 18.1 | 2.8 | 36.15 | 3.66 |
0.2 | 15 (A) | 9.1 | 0.7 | 9.8 | 12.7 | 23.2 | 12.4 | - | - |
14 (B) | 9.8 | 0.6 | 10.4 | 12.8 | 18.4 | 6.1 | 37.14 | 3.84a | |
2 | 18 (A & B) | 8.2 | 0.6 | 8.8 | 13.9 | 36.9 | 5.9 | 31.62 | 3.94b |
300 | 16 (A & B) | 9.6 | 0.4 | 10 | 12.4 | 15.6 | 3.6 | 35.72 | 3.78 |
600 | 16 (A & B) | 10.4 | 0.4 | 10.8 | 13.9 | 20.3 | 3.1 | 37.49 | 3.63 |
A: Mean value includes all surviving animals showing evidence of implantation, including those with total litter loss
B: Mean value includes only animals bearing viable young at termination
Difference from controls statistically significant at Wilcoxon test: aP < 0.05 and bP < 0.001.
Table 4:
a) Group mean incidence for major and minor malformations (Palmer et.al., 1975)
Dosage (mg/kg bw/day) | Number of young | ||||||||
Major malformations | Minor malformations* | ||||||||
Gross or visceral | Skeletal | ||||||||
Examined | Affected | Examined | Affected | Examined | Affected | ||||
Total number | Mean (%) | Total number | Mean (%) | Total number | Mean (%) | ||||
0 | 149 | 0 | 0 | 33 | 1 | 2.2 | 116 | 2 | 2 |
0.2 | 137 | 0 | 0 | 26 | 0 | 0 | 111 | 2 | 1.7 |
2 | 147 | 0 | 0 | 22 | 0 | 0 | 125 | 5 | 5.5 |
300 | 153 | 1 | 0.6 | 30 | 0 | 0 | 122 | 4 | 3.6 |
600 | 166 | 0 | 0 | 34 | 1 | 6.7 | 132 | 2 | 1.8 |
b) Group mean incidence for pups with extra ribs (Palmer et.al., 1975)
Dosage (mg/kg bw/day) | Mean percent incidences of pups with extra lumber ribs* |
0 | 18.6 |
0.2 | 33.1 |
2 | 21.3 |
300 | 12.9 |
600 | 15.3 |
* Young showing major malformations excluded
Applicant's summary and conclusion
- Executive summary:
A pre-natal developmental toxicity study is conducted with C10-13LAS, sodium salt in pregnant female CD rats. The test substance was administered to groups of 20 pregnant female rats via oral gavage at doses of 0, 0.2, 2, 300 and 600 mg/kg bw/day from gestation day 6 (GD 6) till GD 15. All animals were observed daily for clinical signs of toxicity and were weighed regularly throughout the gestation. On GD 17, animals were euthanised and uteri were examined for number of implantations, viable youngs and embryonic deaths (abortion or resorption sites). Ovaries were examined and number of corpora lutea were also recorded. Individual foetus was weighed and examined for external malformations. About one third of the foetuses were examined for visceral anomalies and remaining two thirds for skeletal anomalies. Moderate maternal toxicity was observed at the highest dose due to retarded weight gain and mortality. These effects were associated with the gastrointestinal disturbances. No instances of major, minor and skeletal malformations were observed up to the highest dose of 600 mg/kg bw/day with the exception of a marginal retardation of sternebral ossification at 600 mg/kg. Based on the results, the maternal toxicity and developmental toxicity NOAELs were determined to be 300 mg/kg bw/day based on retarded weight gain and mortality in treated females at higher dose and based on absence of major, minor and skeletal malformations at highest dose respectively (Palmer, 1975a).
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