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EC number: 423-640-6 | CAS number: 179911-08-1 AGARBOIS
- 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:
- 11 June 1996 to 25 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-ethyl-N-(3-methylphenyl)propionamide
- EC Number:
- 423-640-6
- EC Name:
- N-ethyl-N-(3-methylphenyl)propionamide
- Cas Number:
- 179911-08-1
- Molecular formula:
- C12H17NO
- IUPAC Name:
- N-ethyl-N-(3-methylphenyl)propanamide
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd:Sprague-Dawley(CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 235 to 278g
- Housing: individually in metal cages with wire mesh floors in Building R14 Room 6.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 days prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (07:00 - 19:00 hours) in each 24-hour period.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 mm x 50 mm)
- % coverage: 10% of the total body surface
- The treated area was then promptly covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully removed and the treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bodyweight. - Duration of exposure:
- 24 hours with 14 days observation period
- Doses:
- 2.0 g/kg bw
- No. of animals per sex per dose:
- 5 (five males and five females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality
Cages of rats were checked at least twice daily for any mortalities.
Clinical signs
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of approximately five hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation
Bodyweight
Individual bodyweights were recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single dermal application of the test item to a group of ten rats (five males and five females) at a dosage of 2.0 g/kg bodyweight.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats of the test item was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute dermal toxicity of the test item to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.3. Acute toxicity (dermal).
A group of ten rats (five males and five females) was given a single dermal application of the test substance, as supplied, at a dosage of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
There were no deaths and no signs of systemic reaction to treatment.
Desquamation was noted in four females during the early part of the study, accompanied in one animal by transient slight dermal irritation (erythema only) on Day 3. All other sites of application of the test item showed no irritation or other dermal changes.
Slightly low bodyweight gains were recorded for three males on Day 8 with a similar trend noted for three males and three females on Day 15. In addition, zero bodyweight gain was recorded for two females on Day 8, with one further female showing a slight bodyweight loss at this time. All other rats achieved satisfactory bodyweight gains throughout thestudy.
No abnormalities were recorded at the macroscopic examination on Day 15.
The test item was found to be greater than 2.0 g/kg bodyweight.
The test item will not require labelling with the risk phrase R21 "Harmful in contact with skin", in accordance with Commission Directive 93/21/EEC.
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