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Diss Factsheets
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EC number: 213-367-9 | CAS number: 939-97-9
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older proprietary study conducted prior to development of guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Repeat exposure patch test in human volunteers
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-butylbenzaldehyde
- IUPAC Name:
- tert-butylbenzaldehyde
- Test material form:
- other: liquid
- Details on test material:
- The test material was p-tert-butylbenzaldehyde, received from Givaudan Corporation on 8 August 1979, lot number 9942-79. Dosing preparations were described as a clear liquid (2% solution in dimethyl phthalate).
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- The subjects were 26 male and 36 females ranging in age from 16 to 72 years. They were selected based on their willingness to participate, dependability and ability to read and understand instructions, absence of any physical or dermatological condition which would preclude application and reading, understanding and signing an informed consent contract (in the case of minors, parental consent was obtained).
- Clinical history:
- Subjects were free from any physical or dermatological condition which would preclude application of the test material.
- Controls:
- None.
- Route of administration:
- dermal
- Details on study design:
- Induction phase: patches were applied to either the inner arm or the back between the scapulae and waist (depending on volunteer preference). Approximately 0.2 g of test material (2% solution in dimethyl phthalate) was placed onto 2 cm² of Webril affixed to Dermicel tape. The patch was applied and held in place with strips of Blenderm to form an occlusive patch. The patch was removed after 24 hours. Following a rest period of either 24 hours (patches removed on Tuesdays or Thursdays) or 48 hours (patches removed on Saturdays), the test site was scored for signs of irritation and another patch identical to the first was applied. The procedure was repeated until 10 applications had been made. If no irritation was observed subsequent patches were applied to the same site. If a reaction of 2+ or greater was observed then the subsequent patch was applied to a new site and the position recorded. If a minimum of a 2+ reaction was observed in the new site, no further exposures were made (however challenge was still carried out).
Challenge: 10-14 days after application of the final induction patch, the challenge patch was applied to the original contact site and to a fresh, adjacent site. The occlusive patches remained in place for 24 hours, and the sites were scored 24 and 48 hours after application. Subjects were asked to report any delayed reactions occurring after the 48 hour reading.
Results and discussion
- Results of examinations:
- No adverse reactions were observed in any subjects.
Any other information on results incl. tables
No further information.
Applicant's summary and conclusion
- Conclusions:
- No adverse reactions were observed in any subject, therefore it was concluded that 2% p-tert-butylbenzaldehyde is not irritating or sensitising to humans.
- Executive summary:
Twenty six male and thirty six female subjects were exposed dermally to p-tert-butylbenzaldehyde in order to determine its skin irritating and sensitising potential. The test substance (2% solution in dimethyl phthalate) was applied to the skin under an occlusive dressing for ten 24 hour periods, with a rest period of either 24 or 48 hours between exposures. Signs of irritation were recorded prior to application of the patches. A challenge application was made 10 - 14 days after the final induction patch. No signs of irritation or adverse reactions were observed in any subject, therefore it was concluded that a 2% solution of the test material is not irritating or sensitising to human skin.
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