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EC number: 233-634-3 | CAS number: 10287-53-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 July 1987 to 28 July 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- not precised
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- not precised
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- The study was conducted in accordance with quality assurance procedures.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl 4-dimethylaminobenzoate
- EC Number:
- 233-634-3
- EC Name:
- Ethyl 4-dimethylaminobenzoate
- Cas Number:
- 10287-53-3
- Molecular formula:
- C11H15NO2
- IUPAC Name:
- ethyl 4-(dimethylamino)benzoate
- Test material form:
- other: crystalline/powdery solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD [Crl: COBS CD (SD) BR]
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 to 10 weeks of age
- Weight at study initiation: 201 to 226 grams
- Fasting period before study: No
- Housing: Rats were allocated to cages within the treatment group. The rats were housed individually in metal cages with wire mesh floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 22 °C
- Humidity: 69 % (relative)
- Air changes: Approximately 15 per hour
- Photoperiod: 12 hours of artificial light in each 24 hour period
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorso-lumbar region (hair was removed with electric clippers on the day prior to application; no shaving or chemical depilation was used)
- % coverage: 10 % of the total body surface
- Type of wrap if used: Gauze used to cover the treated area was held in place with an impermeable dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm (30 to 40 °C) water was used to wash the area before blotting it with absorbent paper.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 g/kg at a volume of 2.60 mL/kg
- Concentration (if solution): 76.9 % w/v in distilled water
- For solids, paste formed: Yes; prepared as a 76.9 % w/v paste in distilled water on the day of dosing - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of day 1. On subsequent days the animals were observed twice daily. The treated areas of skin were examined daily for signs of dermal irritation and assessed for erythema and eschar and oedema formation. Bodyweights were recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: Yes; on day 15 all animals were killed by cervical dislocation and subjected to macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no deaths following the application of the test material.
- Clinical signs:
- other: There were no clinical signs of systemic reaction to treatment.
- Gross pathology:
- Terminal autopsy findings were normal.
- Other findings:
- DERMAL RESPONSES
At the site of application of the test material no irritation responses or dermal changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the LD50 has been determined to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was conducted to investigate the acute dermal toxicity of the test material in accordance with the standardised guidelines OECD 402 and EU Method B.3.
Five male and 5 female rats received a dermal administration of the test material (as a paste made with distilled water) at a limit dose of 2000 mg/kg bodyweight. Gauze used to cover the treated area was held in place with an impermeable dressing encircled firmly around the trunk. The animals were exposed to the test material for 24 hours before it was washed off with warm water and blotted with absorbent paper. All animals were observed for 14 days after dosing before being terminated on day 15 and subjected to macroscopic examination at necropsy.
All animals survived to study termination and there were no clinical signs of toxicity noted throughout the 14-day study period. Slightly low bodyweight gains were recorded for one male and three females on Day 15. All other animals achieved anticipated bodyweight gains throughout the study. There were no gross pathological findings observed in any animals in the terminal autopsy.
Under the conditions of this study, the LD50 has been determined to be greater than 2000 mg/kg bodyweight.
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