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EC number: 215-355-9 | CAS number: 1323-42-8
- 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
Some information in this page has been claimed confidential.
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Test material form:
- solid
- Remarks:
- soft waxy solid or gel
- Details on test material:
- Melting point of 82 deg C; also reported as 75-77 deg C. Crystallizes from alcohol (ethanol). UV absorption maximum at 295 nm. Additional impurity reports: polyvinyl stearate, up to 2.0% (CASRN not reported, but may be 9003-95-6).
Constituent 1
impurity 1
- Specific details on test material used for the study:
- The test substance in the study was one of two formulations (off white solid) in which 12-HSA comprised 7%. Data supplied to the U.S. CIR from two chemical suppliers stated that the purity of 12-HSA is typically 84.0-84.9%, with impurities of stearic acid (8.3-9.5%), palmitic acid (0.9-1.0%), triglyceride (castor oil, 5.0%) and polyvinyl stearate of < 1.0-2%.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Animals: mated Charles River Crl:CD VAF/Plus female rats, 12.5 weeks of age, weight 211 to 289 g.
Administration / exposure
- Route of administration:
- dermal
- Details on exposure:
- The test substance was applied (with gloved finger) to dorsal skin (clipped free of hair) of each animal, on gestation days 6-15, once daily, and left on for 6 hours each day. The test sites were covered (but not occluded) to prevent ingestion during the study. The control article (described as a clear liquid; no details on its composition were provided) was similarly applied to an additional group rats of the same strain.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- received pre-mated
- Duration of treatment / exposure:
- Days 6-15
- Frequency of treatment:
- once daily, 6 hours per day
- Duration of test:
- 20 days of gestation
Doses / concentrations
- Dose / conc.:
- 7 other: %
- Remarks:
- in formulation
- No. of animals per sex per dose:
- 30 per formulation in 2 formulation groups
- Control animals:
- yes
Examinations
- Maternal examinations:
- clinical signs, condition of skin (especially of exposed area), body weight, gross pathology, reproductive parameters (number of implantations, post-implantation loss, number of corpora lutea, number of resorptions)
- Fetal examinations:
- fetal sex ratio, fetal body weight, uterine weight, number of viable fetuses, number of malformations (skeletal and soft tissue), fetal variations.
- Statistics:
- yes, significance level p < 0.05.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- Both experimental groups displayed increases in the severity of erythema and desquamation at the application sites, compared to controls. Desquamation was observed in 20 of 30 control rats, along with very slight erythema (1 control animal had weel-defined erythema).
- Mortality:
- no mortality observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
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:
- no effects observed
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between experimental and control groups in clinical or necropsy observations. There were no differences between experimental and controls groups in reproductive parameters. In both experimental and control groups, the dermal erythema and desquamation at the application site increased through the 5th and 6th days, then diminished. There was no edema noted in any group. In the control group, 10 rats had very slight erythema and one had well-defined erythema; 20 of 30 had desquamation. In one experimental group, 10 rats had very slight erythema, 10 rats had well defined erytherma, and one rat had moderate to severe erythema; desquamation occurred in 26 rats. In the other experimental group, 16 rats had very slight erythema, 6 had well-defined erythema, and 3 had moderate to severe erythema. Desquamation in this group occurred in 28 of 30 animals.
- Details on maternal toxic effects:
- There were no significant differences between experimental and control groups with respect to implantations, postimplantation losses, corpora lutea, fetal sex ratio, mean fetal body weight or uterine weight. The incidence of postimplantation losses/resorptions was 14 of 325 viabile fetuses in the first experimental group and 20 of 316 viable fetuses in the second experimental group.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 7 other: % in formulation
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- There were no test article-related or statistically significant differences between experimental and control groups. The total number of litters with any malformation was comparable between experimental and control groups. In the first experimental group, the incidence of malformations was 2 of 325 viable fetuses, and in the second group, was 1 of 316 viable fetuses. Fetal variations occurred in 88 of 325 viable fetuses, in Group 1, and in 80 of 316 viable fetuses in Group 2. There were no increases in fetal malformations or variations in the experimental versus control groups.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 7 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- A dermal reproductive toxicity/teratology study (OECD 414) in rats was undertaken on two formulations which included 12-hydroxystearic acid at 7.0%.applied for 6 hours per day, non-occlusive, during organogenesis (days 6-15). There were no increases in deaths, clinical signs, gross pathology or female reproductive parameters, compared to controls. There were no increases in fetal death, malformations or variations over control values. There were increases in erythema but not edema of the skin in experimental groups compared with controls. The dermal NOAEL for systemic maternal toxicity and fetal effects is > 7.0%.
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.
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