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EC number: 801-093-8 | CAS number: 1315251-11-6
- 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:
- supporting study
- Study period:
- 11 Sep 2013 to 18 Oct 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Repeated Insult (occlusive)
- Short description of test conditions: During the induction phase 0.2 mL of 10% of the substance was placed to the back of each subject, every Monday, Wednesday and Friday till 9 applications had been made. The patch was removed after 24 hours. During the challenge phase (after a rest period of 2 weeks) the challenge patch was applied to a previously unpatched test site.
- Parameters analysed / observed: During the induction phase positive reactions of a level 2 erythema or greater results in a change of application site After the challenge, the site was scored after 24, 48 and 72 hours for erythema and oedema - GLP compliance:
- yes
- Remarks:
- Good Clinical Practice Quality Assurance Audit Statement
Test material
- Reference substance name:
- (8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline
- EC Number:
- 801-093-8
- Cas Number:
- 1315251-11-6
- Molecular formula:
- C16H22N2
- IUPAC Name:
- (8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline
- Test material form:
- solid
1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 112
- Sex: Male and female
- Age: 18 - 70 years - Clinical history:
- The subjects did no exhibit any physical or dermatological condition that would have precluded application of the test article or determination of potential effects of the substance
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Occlusive
- Description of patch: 3.63cm^2 patch.
- Concentrations: 10% w/w EtOH:DEP (1:3))
- Volume applied: 0.2 mL
EXAMINATIONS
- Grading/Scoring system: See 1 table in ''Any other information on materials and methods incl. tables''
Results and discussion
- Results of examinations:
- - At 10%, the test material did not demonstrate a potential for eliciting dermal irritation or sensitisation.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions 107
- Number of subjects discontinued study participation: 5
Applicant's summary and conclusion
- Conclusions:
- Based on the test population of 107 subjects and under the conditions of this study, the substance (10% w/w EtOH:DEP(1 :3) did not demonstrate a potential for eliciting dermal irritation or sensitisation
- Executive summary:
112 subjects participated in evaluating the potential of the substance to elicit dermal irritation and/or induce sensitisation. The substance was applied under an occlusive patch to the upper back of each subject and was allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday. Following approximately a 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading. 107 subjects completed the study.
The substance (10% w/w EtOH:DEP(1:3) did not demonstrate a potential for eliciting dermal irritation or sensitisation under the following test conditions: 0.2 mL of the substance applied to a 3.63 cm^2 occlusive patch.
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