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EC number: 811-285-3 | CAS number: 1637294-12-2
- 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:
- 08 September 2016 to 06 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-[2-methyl-4-(2-methylpropyl)phenyl]propanal
- EC Number:
- 811-285-3
- Cas Number:
- 1637294-12-2
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-[2-methyl-4-(2-methylpropyl)phenyl]propanal
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name (as stated in the report): GR-88-0778
Lot No: SC00018060
Aspect: Colourless liquid
Expiration date: 28 April 2017 (expiry date)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) (outbred, SPF-Quality).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany.
- Number of animals: 5 males and 5 females (females were nulliparous and nonpregnant).
- Age and body weight: Young adult animals (approx. 10-11 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
- Identification: Tail mark with indelible ink.
- Health inspection: At least prior to dosing. It was ensured that the animals were healthy and that the skin to be treated was intact and free from any abnormality.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was dosed undiluted as delivered by the Sponsor
- Details on dermal exposure:
- The test item was applied on an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
- Duration of exposure:
- - Frequence: Single dosage, on Day 1.
- Application period: 24 hours, after which dressings were removed and the skin cleaned of residual test item using tap water. - Doses:
- - Dose level (volume): 2000 mg/kg (2.10 mL/kg) body weight. Dose volume calculated as dose level (g/kg) / specific gravity (0.9516).
- No. of animals per sex per dose:
- 1 group of 5 males and 5 females / 1 dose per group
- Control animals:
- no
- Details on study design:
- Initially, NYMPHEAL was administered to three female Wistar rats by a single dermal application at 2000 mg/kg body weight for 24 hours. Based on results, an additional group of two females and five males were dosed at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was scheduled to be performed after terminal sacrifice (Day 15).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Flat posture, piloerection, lethargy, quick breathing, shallow respiration, pstosis and/or chromodacryorrhoea on the snout were noted for all animals between Days 1 and 5.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of NYMPHEAL in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
The acute dermal toxicity with NYMPHEAL in the rat was assessed according the OECD No.402 (1987) "Acute Dermal Toxicity".
Initially, NYMPHEAL was administered to three female Wistar rats by a single dermal application at 2000 mg/kg body weight for 24 hours. Based on results, an additional group of two females and five males were dosed at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was scheduled to be performed after terminal sacrifice (Day 15).
No mortality occurred.
Flat posture, piloerection, lethargy, quick breathing, shallow respiration, pstosis and/or chromodacryorrhoea on the snout were noted for all animals between Days 1 and 5. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination.
The dermal LD50 value of NYMPHEAL in Wistar rats was established to exceed 2000 mg/kg body weight.
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