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EC number: 232-439-0 | CAS number: 8029-68-3 A complex product obtained by the sulfonation and ammoniation of the distillation product from bituminous schists. It may contain saturated and unsaturated hydrocarbons, nitrogen bases and thiophene derivatives.
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January/February 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Ichthammol
- EC Number:
- 232-439-0
- EC Name:
- Ichthammol
- Cas Number:
- 8029-68-3
- Molecular formula:
- unspecified
- IUPAC Name:
- Ichthammol (UVCB substance)
- Test material form:
- liquid: viscous
- Details on test material:
- sample from a batch from regular production released for use as an active pharmaceutical ingredient in medicinal products.
1
- Specific details on test material used for the study:
- The test substance was taken from a regular production batch (CH.029213, 5/82) at the registrant's manufacturing site. At the time of conduct of the study the test substance in general has been used for treatment of skin disorders in human medicine for many decades.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The experimental animals were male and female Sprague-Dawley rats (a crossbred from breeder "Lippische Versuchstierzucht, Hagemann GmbH & Co., D-4923 Extertal 1, Germany") weighing between 160 and 170 g. The initial age was 42 days for the males and 40 days for the females.
The animals were fed the commercial feed ALTROMIN 1324, manufacturer ALTROMIN GmbH, D-4937 Lage/Lippe, Germany. The animals were deprived of food 16 - 18 hours before the beginning of the study; subsequently, both food and water were available ad libitum (except on the day of treatment).
During the follow up observation period the animals were housed in pairs in MAKROLON cages (type III) at a room temperature of 21 +- 1.0°C and a relative humidity of 55 +- 5%. The colony room was illuminated (approx. 150 lux at 1.50 m above the floor) from 6 a.m. to 6 p.m. and kept dark from 6 p.m. - 6 a.m.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Principle: The test substance was applied to rats once for 24 hours on the shaved intact dorsal skin (5.0 x 6.0 cm, 1/10 of the body surface area).
The application site was shaved without injury with a hand shaver. The site was approximately 5.0 x 6.0 cm and was located between the front and rear extremities on the backs of the animals.
The test substance was applied undiluted on a 5-layered gauze pad, covered over with a piece of plastic foil of the same size and attached between the foreleges and hind legs using a rubberized bandage. - Duration of exposure:
- 24 hours
- Doses:
- 2 doses (17800 and 21500 mg/kg K.G., corresponding to a volume of 17.1 and 20.7 ml/kg body weight) were tested on 2 animals with intact skin. The dose interval followed the factor 1.21.
- No. of animals per sex per dose:
- Two per sex per dose
- Control animals:
- no
- Details on study design:
- Principle: The test substance is applied to rats once for 24 hours on the shaved intact dorsal skin (5.0 x 6.0 cm, 1/10 of the body surface area). After the exposure the backs of the animals were washed off with lukewarm water (30°C) and then swabbed. The treatment phase is followed by a 14-day follow-up observation period in which the following criteria are checked: skin reaction, behaviour, general condition, food intake and development of body weight.
At the end of the observation period, all animals were sacrificed, dissected and macroscopically examined. - Statistics:
- If applicable, the LD50 is calculated according to LITCHFIELD and WILCOXON. This is based on the mortality rates within 24 hours and 14 days.
Results and discussion
- Preliminary study:
- No special sighting study was carried out.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 21 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortalities in the study
- Clinical signs:
- other: No clinical signs in the study
- Gross pathology:
- Postmortem examination without pathological findings
- Other findings:
- No developement of erythema. No development of edema. No intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of Ichthammol was investigated in vivo in rats at a dose level up to 21500 mg/kg b.w. in a GLP guideline study. No local skin reactions and no specific clinical symptoms were evident in the dose groups applied (there were no signs of erythema or edema). No specific pathological findings were evident on macroscopical examination at the end of the post-observation period. No changes in body weight development and food intake was observable. The LD50 was estimated to be > 21500 mg/kg b.w. (males and females).
Based on the findings of this study there is no need to carry out a special study on skin irritation / corrosion.
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