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EC number: 211-402-2 | CAS number: 643-79-8
- 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:
- 1989-06-22 to 1989-10-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted: 24th February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Phthalaldehyde
- EC Number:
- 211-402-2
- EC Name:
- Phthalaldehyde
- Cas Number:
- 643-79-8
- Molecular formula:
- C8H6O2
- IUPAC Name:
- phthalaldehyde
Constituent 1
- Specific details on test material used for the study:
- - Appearance: Light yellow needles
- Batch No.: 1
- Purity: GC (area %) 99%
- Stablity of the test article: Stable
- Expiration date: 1989-12-31
- Stability of test article dilution: Stable for at least 48 hours
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: males: 9 weeks, females: 11 weeks
- Weight at study initiation: males: 216 - 229 g, females: 186 - 199 g
- Housing: Animals were housed individually in Makrolon type-2 cages with standard softwood bedding
- Diet (e.g. ad libitum): Ad libitum, pelleted standard Kliba 343, Batch 46/89 rat maintenance diet
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back of the animal
- % coverage: approx. 10 % of total body surface
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin was washed with lukewarm tap water, dried with disposable paper towels
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Concentration (if solution): 2000 mg/kg - Duration of exposure:
- 15 days
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females tested at a single dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: Four times during test day 1, and daily during days 2 - 15 (mortality, viability and clinical signs). Due to the 24-hour semi-occlusive treatment, the local findings were ob erved starting with day 2 of test.
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- The LOGIT-Model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- The following local signs were observed on the back of the animals:
2000 mg/kg: males/females - edema, general erythema, necroses, skin black. Additional edema was observed in the female rats.
The symptoms as described above were partly observed until termination of test. No clinical signs were observed in the animals throughout the study. - Body weight:
- A decrease in body weights was observed in 2 male and 4 female rats between days 1 and 8 of the test period. The body weight gain had recovered to normal at termination of the observation period (day 15).
- Gross pathology:
- The following macroscopical organ findings were observed:
2000 mg/kg: sacrificed - kidneys: discoloration, pale
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the dermal LD50 of the test material was greater than 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study conducted according to OECD guideline 402, young adult Wistar rats (5/sex/dose) were administered with a single occlusive application of ortho-phthalaldehyde in polyethylene glycol at a dose of 2000 mg/kg bw and were observed for 15 days. Due to the absence of mortality and low adverse clinical signs, the oral LD50 in rats is considered to be greater than 2000 mg/kg. In this study, ortho-phthalaldehyde does not warrant classification for acute dermal toxicity based on CLP criteria.
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