Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-634-3 | CAS number: 10287-53-3
- 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

Endpoint summary
Administrative data
Description of key information
Based on the available data, Ethyl 4-dimethylaminobenzoate induced no mortality in rats after one administration of 2000 mg/kg/day by oral or dermal route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 July 1987 to 30 July 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- not precised
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- 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
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD [Crl: COBS CD (SD) BR]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Four to six weeks old
- Weight at study initiation: 104 to 120 grams
- Fasting period before study: Overnight before dosing and for four hours post dosing (restricted access to food only)
- Housing: Rats were allocated to cages within the treatment group, housed in groups by sex in metal cages with wire mesh floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 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 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Stability: Not determined; the test material was prepared on the day of dosing
MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females 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 day 1. On subsequent days, observations took place twice daily. Individual bodyweights were recorded on days 1, 8 and 15.
- Necropsy of survivors performed: All animals were killed on day 15 by cervical dislocation and macroscopic post mortem examination took place which consisted of opening the abdominal and thoracic cavities. - 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 a single oral dose of test material at 2000 mg/kg bodyweight.
- Clinical signs:
- other: Signs of reaction to treatment observed shortly after dosing in all animals were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and pallor of extremities. Recovery, as judged by external appearance and behaviou
- Gross pathology:
- Terminal autopsy findings were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the acute lethal oral dose was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 401 and EU Method B1.
A group of 5 male and 5 female rats were exposed to the test material in corn oil at a limit dose of 2000 mg/kg bw. Fasted animals were dosed via a syringe and plastic catheter. All animals were observed for 14 days after dosing before being terminated on day 15 and subjected to macroscopic examination at necropsy.
There were no cases of mortality during the study. Signs of reaction to treatment observed shortly after dosing in all animals were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and pallor of extremities. Recovery, as judged by external appearance and behaviour, was advanced by Day 2 and complete by Day 3. Terminal autopsy findings were normal.
Under the conditions of this study the acute lethal oral dose was found to be greater than 2000 mg/kg bodyweight.
Reference
Table 1: Signs of reaction to treatment observed
Signs |
No. of animals in group of 5 showing signs at 2000 mg/kg |
|
Male |
Female |
|
Pilo-erection |
5 |
5 |
Hunched posture |
5 |
5 |
Waddling |
5 |
5 |
Lethargy |
5 |
5 |
Pallor of extremities |
5 |
5 |
Table 2: Individual bodyweights
Sex |
Bodyweight (g) at Day |
||
1 |
8 |
15 |
|
Male |
120 104 120 112 119 |
195 163 186 175 182 |
248 207 234 229 236 |
Female |
107 114 111 119 112 |
147 152 148 169 155 |
169 182 173 197 184 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One study is available to address this endpoint. The study was performed in accordance with standardised guidelines. The quality of the database is therefore considered to be good.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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
- 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 - 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. - 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One study is available to address this endpoint. The study was performed in accordance with standardised guidelines. The quality of the database is therefore considered to be good.
Additional information
Oral
The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 401 and EU Method B1. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
A group of 5 male and 5 female rats was exposed to the test material in corn oil at a limit dose of 2000 mg/kg bw. Fasted animals were dosed via a syringe and plastic catheter. All animals were observed for 14 days after dosing before being terminated on day 15 and subjected to macroscopic examination at necropsy.
There were no cases of mortality during the study. Signs of reaction to treatment observed shortly after dosing in all animals were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and pallor of extremities. Recovery, as judged by external appearance and behaviour, was advanced by Day 2 and complete by Day 3. Terminal autopsy findings were normal.
Under the conditions of this study the acute lethal oral dose was found to be greater than 2000 mg/kg bodyweight.
Dermal
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. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
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.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral or dermal route.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
Questo sito web si avvale di cookie affinché possiate usufruire della migliore esperienza sui nostri siti web.