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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
- 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
Developmental toxicity / teratogenicity
Administrative data
- 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of the teratogenic potential of surfactants. Part I - LAS, AS, and CLD
- Author:
- Palmer, A.K., Readshaw, M.A., and Neuff, A.M.
- Year:
- 1 975
- Bibliographic source:
- Toxicology. 3:91-106
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Linear Alkylbenzene Sulphonate (LAS)
- IUPAC Name:
- Linear Alkylbenzene Sulphonate (LAS)
- Details on test material:
- Supplied by Lion Fat & Oil Co., Tokyo
Constituent 1
Test animals
- 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).
Administration / exposure
- 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
Doses / concentrationsopen allclose all
- 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
Examinations
- 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.
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 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
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:
- 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.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
Maternal abnormalities
- Abnormalities:
- no effects observed
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:
- 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.
Effect levels (fetuses)
- 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
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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