Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 452-330-3 | CAS number: -
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 July 2003 to 27 August 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 452-330-3
- EC Name:
- -
- Cas Number:
- 314020-40-1
- Molecular formula:
- C14H20N2O2
- IUPAC Name:
- 2-(2,6-diethyl-4-methyl-phenyl)propanediamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: Powder, yellowish
- Storage condition of test material: In the dark at ambient temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD (Wistar-derived)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 186-245 g
- Fasting period before study: Rats were fasted overnight prior to dosing
- Housing: 5 per cage
- Diet: ad libitum
- Water: Mains water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 per hour minimum
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark
IN-LIFE DATES: From: 30 July 2003 To: 27 August 2003
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % w/v (aqueous)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Doses were prepared by adjusting the concentration of the test material in the dosing preparations
- Amount of vehicle (if gavage): Each dose volume was calculated for animals individually based on its weight at the time of dosing.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight was administered as a standard dose volume - Doses:
- Sighting study: 300 or 2000 mg/kg bodyweight
Main test: 300 or 2000 mg/kg bodyweight - No. of animals per sex per dose:
- Sighting study: one initially
Main test: A further four animals were tested from both dosing groups - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were examined for physical and behavioural abnormalities prior to dosing. Post dosing, animals were examined for systemic toxicity twice on day 1 and daily up to day 15 thereafter. All animals were weighed prior to fasting, immediately before dosing and on days 8 and 15.
- Necropsy of survivors performed: Animals were sacrificed by halothane vapour overdose followed by exsanguination. All animals were subject to a macroscopic examination of the thoracic and abdominal viscera. All abnormalities were recorded but tissues were not submitted for histopathological examination.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Following a single oral dose of 300 mg/kg, none of the animals died. Signs of slight systemic toxicity were seen in all animals, with complete recovery by day 2. Following a single oral dose of 2000 mg/kg four of the animals showed signs of toxicity including (in two animals) convulsions and were killed in extremis on day 1.
- Clinical signs:
- In the 300 mg/kg dose group, signs of slight systemic toxicity were seen in all animals, with complete recovery by day 2. Following a single oral dose of 2000 mg/kg four of the animals showed signs of toxicity including (in two animals) convulsions and were killed in extremis. The surviving animal in this group was fully recovered by day 2.
- Body weight:
- All animals initially lost weight due to the pre-dose fast but all surviving animals showed an overall bodyweight gain during the study.
- Gross pathology:
- One animal dosed with 300 mg/kg was found to have a speckled thymus at post mortem. This was a spontaneous finding and was not considered to be related to treatment. One of the animals killed in extremis after dosing with 2000 mg/kg had red staining around the nose and mouth. This was a non-specifiec finding related to treatment.
Any other information on results incl. tables
Table 1: Bodyweights of female rats dosed with 300 or 2000 mg/kg of test material
Dose |
Animal no. |
Day |
||||
Pre-dosing (day -1) |
Dosing (day 1) |
day 2 |
day 8 |
Terminal (day 15) |
||
300 mg/kg |
49 |
206 |
184 |
Not performed |
231 |
246 |
4 |
190 |
168 |
Not performed |
243 |
264 |
|
5 |
192 |
168 |
Not performed |
230 |
242 |
|
6 |
192 |
173 |
Not performed |
225 |
233 |
|
7 |
186 |
170 |
Not performed |
234 |
239 |
|
2000 mg/kg |
63 |
245 |
218 |
227 |
282 |
311 |
72 |
199 |
181 |
- |
- |
- |
|
73 |
209 |
191 |
- |
- |
- |
|
74 |
243 |
194 |
- |
- |
- |
|
75 |
202 |
188 |
- |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Classification derived using the criteria reported in Annex II of the OECD Guideline 420. Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the highest fixed dose of the test material administered in this study without causing any lethality (i.e. the discriminating dose-level) was 300 mg/kg to female rats. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The acute oral toxicity of the test material was determined in accordance with the standardised guideline OECD 420 using the fixed dose procedure. Single female rats initially received one oral dose of 300 or 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. From the results of the initial phase, fixed dose levels of 300 and 2000 mg/kg were selected for the main phase study. In the main phase, groups of four female rats were dosed and assessed for signs of toxicity for 14 days following dosing. Bodyweights were recorded at intervals during the study. Animals in extremis and those surviving to the end of the study were killed and, together with those found dead, were examined post mortem. The initial females were included in the main phase of the study, to give a total of five animals per group.
None of the animals in the 300 mg/kg group died. Signs of slight systemic toxicity were seen in all animals, all of which had fully recovered by day 2. All animals showed an overall bodyweight gain during the study. There were no treatment related abnormalities post mortem. Following a single oral dose of 2000 mg/kg, four of the animals showed signs of severe toxicity including (in two animals) convulsions and were killed in extremis on day 1. The surviving animal showed signs of toxicity following dosing but had recovered by day 2 and showed an overall body weight gain during the study. At examination post mortem one of the animals killed in extremis had red staining around the nose and mouth.
The highest fixed dose of the test material administered in the study without causing any lethality (i.e. the discriminating dose-level) was 300 mg/kg to female rats.
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.