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EC number: 412-570-1 | CAS number: 119462-56-5 PERKALINK 900
- 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:
- supporting study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: See below, a 5-day RF study was started but had to be finished prematurely because of rapid and severe skin reactions.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- The 28-day test was cancelled because of rapid and severe skin reactions during the 5-day dose range-finding test. See below.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
- EC Number:
- 412-570-1
- EC Name:
- 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
- Cas Number:
- 119462-56-5
- Molecular formula:
- Hill formula: C18 H16 N2 O4
- IUPAC Name:
- 3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on exposure:
- The test substance formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
- Duration of treatment / exposure:
- 6 hours per day for 5 days
- Frequency of treatment:
- Once daily for 5 days. Application was performed approximately the same time each day.
- No. of animals per sex per dose:
- 3 per sex/dose for 300 and 1000 mg/kg bw groups
3 males for 30 and 100 mg/kg bw groups - Details on study design:
- Dose levels of 30 and 100 mg/kg/day were based on the results of a previous pilot study using dose levels of 300 and 1000 mg/kg/day (NOTOX project 326734). In that study severe irritation/corrosion was observed among all animals.
Since a dose volume higher than 7.5 ml/kg is practically impossible taking into account the size of the patch and the maximum body weights to be expected in the main study, dose levels lower than 300 mg/kg/day were selected in order
to minimize/prevent ethically unacceptable irritation.
Results and discussion
Results of examinations
- Dermal irritation:
- effects observed, treatment-related
- Details on results:
- In a 5 day dermal range-finding study corrosive effects were observed at the 1000 and 300 mg/kg dose level. Therefore, a new pilot study was conducted using dose levels of 30 and 100 mg/kg body weight/day at the maximized dose volume of 7.5 ml/kg body weight. Again severe local effects were noted. As in the first pilot study no skin effects were seen on the first 2-3 days of treatment but appeared on day 3 and later. Thus, these effects may likely be related to the sensitisizing capacity of PERKALINK 900 (as indicated in a Guinea Pig Maximisation Test). Treatment of further animals at lower dose levels was was deemed not to provide useful information with regard to systemic toxicity.
Any other information on results incl. tables
Based on the acute dermal toxicity study (LD50 > 2000 mg/kg bw), a 5-day dermal range-finding study was carried out with 1000 and 300 mg/kg bw/day. This resulted in severe skin damage with local or generalised erythema, necrosis and scab formation. Renewed range finding with 100 and 30 mg/kg bw/day gave identical results, viz. 30 mg/kg bw induced severe local effects appearing on days 3, 4 and 5.
Applicant's summary and conclusion
- Executive summary:
In a 5 day dermal range-finding study corrosive effects were observed at the 1000 and 300 mg/kg dose level. Therefore, a new pilot study was conducted using dose levels of 30 and 100 mg/kg body weight/day at the maximized dose volume of 7.5 ml/kg body weight. Again severe local effects were noted. As in the first pilot study no skin effects were seen on the first 2-3 days of treatment but appeared on day 3 and later. Thus, these effects may likely be related to the sensitisizing capacity of PERKALINK 900 (as indicated in a Guinea Pig Maximisation Test). Treatment of further animals at lower dose levels was was deemed not to provide useful information with regard to systemic toxicity.
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