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Diss Factsheets
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EC number: 701-461-7 | 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study meets the criteria for Klimisch code 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 68783-96-0
- Cas Number:
- 68783-96-0
- IUPAC Name:
- 68783-96-0
- Reference substance name:
- petroleum derived calcium salt, overbased
- IUPAC Name:
- petroleum derived calcium salt, overbased
- Details on test material:
- the test material described as a petroleum derived calcium salt, overbased, belongs to the same chemical group as the submission substance (aryl / alkyl sulfonates). The alkyl chain lengths are, however, unspecified.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague Dawley CD rats, 8-9 weeks of age at initiation
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- test substance was applied undiluted to the clipped dorsal surface for periods of 6h per day of study. material was held in place by a gauze patch secured with tape. after each exposure period the treated area was wiped. the procedure was repeated daily for 28d.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6h per day for 28d
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100,300 and 1000 mg/kg bwt
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, sham-exposed
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- clinical observations daily
dermal reposes on days 0,1,4,7,11,14,18,21,25 and prior to blood collection on d28
body weight and food consumption during treatment and recovery
Hematology and clinical chemistry at termination of treatment and recovery
Microscopic examination on all animals - Sacrifice and pathology:
- full range of evaluations performed
- Statistics:
- ANOVA with Dunnets test, Kruskal-Walis, Dunns summed rank test , Jonkheere test for monotonic trend, Students t test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No mortality occurred during the study. Low incidences of very slight erythema, desquamation and / or pinpoint scabbing were observed sporadically in all treated animals. all animals were free of edema during the study. Body weights and food consumption were unremakable. There were no treatment related differences in heamatology. Differences from control were noted for several heamatology parameters including a statistically significant increase in mean % of neutrophils of 300 and 1000 mg/kg females and a decrease in mean % of lymphocytes in the 1000mg/kg females compared to controls on d28. In the absence of differences from control in absolute white blood cell counts, these findings were not considered related to treatment. There was a statistically significant decrease in mean corpuscular haemoglobin concentration in the male satellite animals from d28-42. In the absence of other significant findings these small differences were not considered clinically significant. Serum chemistry values were unremakable. Gross mostmortem findings were considered incidental and unrelated to treatment. There were no alterations in organ weights that were attributed to treatment.There were no test material related microscopic findings noted in any group. Effects on the skin were seen in all groups including control but tended to increase in male treated animals and females in the 300 and 1000 mg.kg groups, indicating a mild irritant effect of the test article
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Organ:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No evidence of systemic toxicity via the dermal route.
- Executive summary:
The test substance exhibited no evidence of systemic toxicity via the dermal route under the conditions of this study when exposed to 5 Sprague Dawley CD rats/sex/dose over a period of 28 days. A NOAEL of >1000 mg/kg bwt was established.
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