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Diss Factsheets
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EC number: 948-935-1 | CAS number: -
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- An old study whic pre-dates GLP but method follows the principles of OECD 414
Data source
Reference
- Reference Type:
- publication
- Title:
- TERATOLOGY STUDIES OF A MIXTURE OF TALLOW ALKYL ETHOXYLATE AND LINEAR ALKYLBENZENE SULFONATE IN RATS AND RABBITS
- Author:
- GRANVILLE A. NOLEN, LLOYD W. KLUSMAN, LARRY F. PATRICK and
ROBERT G. GEIL - Year:
- 1 975
- Bibliographic source:
- Toxicology, 4 (1975) 231--243
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
Test material
- Reference substance name:
- Tallow alkyl ethoxylate
- Molecular formula:
- Not known - UVCB
- IUPAC Name:
- Tallow alkyl ethoxylate
- Reference substance name:
- Linear alkylbenzene sulfonate
- Molecular formula:
- Not known - UVCB
- IUPAC Name:
- Linear alkylbenzene sulfonate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- A mixture of 55% tallow alkyl ethoxylate sulfate (TAE 3 S) and 45% of linear alkylbenzene sulfonate (LAS)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- The rats were contained individually in suspended, stainless steel wire cages, except during the mating and nursing phases. Ground Purina Chow and water were available ad libitum throughout the study. The room temperature was maintained at 23 _+ 1 ° and the relative humidity at 50 -+ 5%. Lighting was maintained on a 12-h light--dark cycle
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- The TAE 3 S/LAS was mixed into the ground commercial feed at levels of 0.1, 0.5 or 1.0% and fed to two generations of male and female rats continuously or only to females during each period of organogenesis (days 6--15) of pregnancy. A control group was fed commercial feed with no additive.
- Details on mating procedure:
- After becoming sexually mature, five rats of each sex per group were sacrificed for histology during each generation. The remaining animals were mated on a one-to-one basis three successive times during each generation. Pregnancies were confirmed and timed by the vaginal smear method and the day of finding sperm was designated day "0" of pregnancy. The first two pregnancies (F 1 a,1 b.2 a an a 2 b ) in each generation were allowed to proceed to natural births, while the third pregnancies in each generation (F1¢ and F2c ) were used for teratology.
- Duration of test:
- Days 6-15 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 80 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 800 mg/kg bw/day
- No. of animals per sex per dose:
- 25/sex/dose
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 6r ats in total died, 3 were in the control group and 3 in treated groups. heir deaths were due to disease and were not considered to be treatment related.
- Body weight and weight changes:
- not specified
- 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:
- no effects observed
- Description (incidence and severity):
- No significant differences were seen in the haematology values nor in the organ/body weight ratios.
- 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
- Details on results:
- No significant differences in haematology values nor in the body/organ weight ratios.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- 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
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: No effects seen. NOAEL is highest tested dose
Results (fetuses)
- Fetal body weight changes:
- not specified
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- 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
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects seen. NOAEL is highest tested dose
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test material did not show any developmental effects after rats were administered doses of hte test material through the organogenesis period. there were no significant differences in the number of resorptions at 13 days of gestation, thus no early embryotoxicity. In addition, there were no differences in the number of corpora lutea or total implantations in either generation. There were no significant foetal mortalities,a s indicated by the low number of dead foetuses and resorption sites in dams sacrificed at day 21 of pregnancy. Most of the soft tissue abnormalities seen in the rat foetuses were minor ones, more properly called variations rather than true defects such as hydrnephrosis, ectopic testes and folded retina, although two rats were seen with umbical hernia in the first generation. Similarly, the skeletal defects were minor in nature, including variations in the number of sternbrae, supernumeracy ribs and incomplete ossification
- Executive summary:
The test material did not show any developmental effects after rats were administered doses of hte test material through the organogenesis period. there were no significant differences in the number of resorptions at 13 days of gestation, thus no early embryotoxicity. In addition, there were no differences in the number of corpora lutea or total implantations in either generation. There were no significant foetal mortalities,a s indicated by the low number of dead foetuses and resorption sites in dams sacrificed at day 21 of pregnancy. Most of the soft tissue abnormalities seen in the rat foetuses were minor ones, more properly called variations rather than true defects such as hydrnephrosis, ectopic testes and folded retina, although two rats were seen with umbical hernia in the first generation. Similarly, the skeletal defects were minor in nature, including variations in the number of sternbrae, supernumeracy ribs and incomplete ossification
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