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EC number: 291-813-1 | CAS number: 90480-76-5
- 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:
- 23 May 2018 - 24 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 1-[(5-amino-4-methylpentyl)amino]-3-(2-methylphenoxy)-propan-2-ol
- Cas Number:
- 1617528-43-4
- Molecular formula:
- C16H28N2O2
- IUPAC Name:
- 1-[(5-amino-4-methylpentyl)amino]-3-(2-methylphenoxy)-propan-2-ol
- Reference substance name:
- 1,1'-[(2-Methyl-1,5-pentanediyl)diimino]bis[3-(2-methylphenoxy)-propan-2-ol]
- Cas Number:
- 1617528-45-6
- Molecular formula:
- C26H40N2O4
- IUPAC Name:
- 1,1'-[(2-Methyl-1,5-pentanediyl)diimino]bis[3-(2-methylphenoxy)-propan-2-ol]
- Reference substance name:
- Mephenesin
- EC Number:
- 200-427-4
- EC Name:
- Mephenesin
- Cas Number:
- 59-47-2
- Molecular formula:
- C10H14O3
- IUPAC Name:
- 3-(2-methylphenoxy)propane-1,2-diol
- Reference substance name:
- 1,3-bis(2-methylphenoxy)propan-2-ol
- Cas Number:
- 17181-49-6
- Molecular formula:
- C17H20O3
- IUPAC Name:
- 1,3-bis(2-methylphenoxy)propan-2-ol
- Reference substance name:
- 2-methylpentane-1,5-diamine
- EC Number:
- 239-556-6
- EC Name:
- 2-methylpentane-1,5-diamine
- Cas Number:
- 15520-10-2
- Molecular formula:
- C6H16N2
- IUPAC Name:
- 2-methylpentane-1,5-diamine
- Reference substance name:
- 3,3’-(5-(2-hydroxy-3-(o-tolyloxy)propylamino)-4-methylpentylazanediyl)bis(1-(o-tolyloxy)propan-2-ol)
- Molecular formula:
- C36H52N2O6
- IUPAC Name:
- 3,3’-(5-(2-hydroxy-3-(o-tolyloxy)propylamino)-4-methylpentylazanediyl)bis(1-(o-tolyloxy)propan-2-ol)
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 209 g
- Fasting period before study:
- Housing: individually throughout the study in suspended solid floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet , ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- After the 24 Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with dimethyl sulfoxide followed by distilled water to remove any residual test item.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1000 mg/kg bw, corresponding to 0.96 mL/kg bw
- Concentration (if solution): neat substance
- Duration of exposure:
- 24 h
- Doses:
- 1000 mg/kg bw
- No. of animals per sex per dose:
- 1 female
- Control animals:
- no
- Details on study design:
- The animal was observed for deaths or overt signs of toxicity 30 minutes, 1, 2, 4 and 6 hours after dosing and on Day 1. After removal of the dressings the test sites were examined for evidence of primary irritation.
The animal was humanely killed by cervical dislocation on Day 1. The animal was subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities and examination of the sub-cutaneous layer below the treatment site. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Remarks on result:
- not determinable
- Remarks:
- The dermal LD50 of the test item could not be accurately evaluated due to the corrosive nature of the test item.
- Mortality:
- The animal was killed for humane reasons due to due to the corrosive nature of the test item in accordance with the severity limit set forth in the UK Home Office Project License.
- Clinical signs:
- other: Clinical signs noted one day after dosing were hunched posture, lethargy and tiptoe gait. It was considered that these signs may have been due to the dermal reactions causing uncomfortable movement as opposed to systemic toxicity.
- Gross pathology:
- Full thickness necrosis and hemorrhage of the underlining tissues were noted at the visual inspection of the sub-cutaneous layer at the treatment site.
- Other findings:
- Dark green dermal necrosis over the majority of the treatment site was surrounded by a margin of blanching and moderate erythema.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The acute dermal median lethal dose (LD50) of CGE-PMDA adduct could not be accurately evaluated due to the corrosive nature of the test item.
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test item CGE-PMDA adduct in the Wistar strain rat.
One female animal was given a single, 24-hour, semi‑occluded dermal application of the undiluted test item to intact skin at a dose level of 1000 mg/kg body weight. Based on the results of the initial animal, no further animals were treated. Clinical signs and body weight development were monitored during the study. The animal was subjected to gross necropsy.
Mortality. The animal was killed for humane reasons due to the corrosive nature of the test item in accordance with the severity limit set forth in the UK Home Office Project License.
Clinical Observations. Clinical signs noted one day after dosing were hunched posture, lethargy and tiptoe gait.
Dermal Irritation. Dark green dermal necrosis over the majority of the treatment site surrounded by a margin of blanching and moderate erythema was noted one day after dosing.
Body Weight. The animal lost weight over the study period.
Necropsy. Full thickness necrosis and hemorrhage of the underlining tissues were noted at the visual inspection of the sub-cutaneous layer at the treatment site.
The acute dermal median lethal dose (LD50) of the test item in the female Wistar strain rat could not be accurately evaluated due to the corrosive nature of the test item.
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