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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 September 2003 to 07 October 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to GLP and in line with the standardised guideline OECD 402, EU Method B.3 and EPA OPPTS 870.1200 with no deviations thought to impact the reliability of the presented results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: Powder, yellowish
- Storage condition of test material: Ambient temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD (Wistar-derived)
- Sex:
- male/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: 255-276 g males, 190-207 g females
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum, mains water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes minimum
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark
IN-LIFE DATES: From: 10 September 2003 To: 7 October 2003
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorso-lumbar region of each animal (7 cm x 7 cm area was clipped free of hair with veterinary clippers to allow administration of the test material).
- Type of wrap if used: The test substance was applied to the shorn back of each animal and was kept in contact with the skin for approximately 24 hours using an occlusive dressing wrapped around the trunk. Each dressing consisted of a foil backed gauze patch to cover the treated area and was held in place by a cohesive bandage secured with two pieces of surgical tape.
REMOVAL OF TEST SUBSTANCE
- Washing: The dressings were carefully cut using blunt tipped scissors, removed and discarded. The skin at the site of application was cleansed of any residual test material using clean swabs of absorbent cotton wool soaked in clean warm water and then dried gently with clean tissue paper.
- Time after start of exposure: At the end of the 24 hour contact period.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The amount of test material applied was calculated for each animal according to its weight at the time of dosing.
- For solids, paste formed: The test material was moistened to a dry paste with a small amount (1 mL) of water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females per group
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Prior to the start of the study, all rats were examined for any physical or behavioural abnormalities. The animals were observed twice following application on day 1 (only gross abnormalities were noted at this time as the presence of the dressings may have affected the behaviour and movement of the rats). Subsequent observations for signs of systemic toxicity and skin irritation were made once daily up to day 15. The animals were weighed immediately before dosing (day 1) and on days 8 and 15 (termination).
- Necropsy of survivors performed: All animals were killed by an overdose of halothane vapour followed by exsanguination. All animals were examined post mortem. An external observation was performed and a detailed examination of all thoracic and abdominal viscera. All abnormalities were recorded but tissues were not submitted for histopathological examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the course of the study. None of the animals exhibited signs of systemic toxicity.
- Clinical signs:
- All the animals were stained yellow by the test substance for up to 5 days. Signs of slight skin irritation were seen in all animals but had completely resolved by day 14.
- Body weight:
- All animals gained weight during the study.
- Gross pathology:
- There were no macroscopic abnormalities at examination post mortem.
Any other information on results incl. tables
Table 1: Body weights
Sex |
Animal no. |
Day |
||
Day of dosing (Day 1) |
Day 8 |
Terminal (Day 15) |
||
Male |
1 |
276 |
313 |
357 |
2 |
263 |
309 |
379 |
|
3 |
255 |
304 |
366 |
|
4 |
274 |
324 |
392 |
|
5 |
261 |
307 |
371 |
|
Mean |
265.8 |
311.4 |
373 |
|
S.D. |
8.9 |
7.8 |
13.3 |
|
Female |
6 |
203 |
227 |
264 |
7 |
190 |
195 |
218 |
|
8 |
197 |
215 |
242 |
|
9 |
207 |
222 |
227 |
|
10 |
195 |
206 |
222 |
|
Mean |
198.4 |
213.0 |
234.6 |
|
S.D. |
6.7 |
12.8 |
18.8 |
Table 2: Irritation observations
Sex |
Animal no. |
Observation |
Day |
|||||||||||
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
|||
Male |
1 |
Desquamation |
S |
S |
S |
S |
S |
S |
S |
|||||
Erythema |
S |
S |
S |
|||||||||||
Oedema |
S |
|||||||||||||
Scabs: small scattered |
P |
P |
P |
P |
P |
P |
P |
|||||||
2 |
Desquamation |
S |
S |
S |
S |
S |
S |
S |
||||||
Erythema |
S |
|||||||||||||
Scabs: small scattered |
P |
P |
P |
P |
P |
P |
P |
|||||||
3 |
Desquamation |
S |
S |
S |
S |
S |
||||||||
Oedema |
S |
|||||||||||||
Scabs: small scattered |
P |
|||||||||||||
Scab: edge of application area |
P |
P |
P |
|||||||||||
4 |
Desquamation |
S |
S |
S |
S |
S |
S |
S |
S |
S |
S |
S |
||
Oedema |
S |
|||||||||||||
Scabs: small scattered |
P |
P |
P |
P |
P |
P |
P |
P |
P |
P |
||||
5 |
Desquamation |
S |
S |
|||||||||||
Oedema |
S |
|||||||||||||
Scabs: small scattered |
P |
|||||||||||||
Scab: edge of application area |
P |
P |
||||||||||||
Female |
6 |
Desquamation |
S |
S |
S |
S |
S |
S |
S |
S |
||||
Erythema |
S |
S |
||||||||||||
Oedema |
S |
|||||||||||||
Scabs: small scattered |
P |
P |
P |
P |
P |
P |
P |
P |
||||||
7 |
Desquamation |
S |
S |
|||||||||||
Scab: edge of application area |
P |
P |
P |
P |
P |
P |
||||||||
8 |
Desquamation |
S |
S |
S |
S |
S |
S |
S |
||||||
Oedema |
S |
|||||||||||||
Scabs: small scattered |
P |
P |
P |
P |
P |
P |
P |
|||||||
Scab: edge of application area |
P |
P |
P |
|||||||||||
9 |
Desquamation |
S |
S |
|||||||||||
10 |
Oedema |
S |
||||||||||||
Scab: edge of application area |
P |
P |
P |
P |
P |
P |
P = Present
S = Slight
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information The test material failed to elicit any toxicological response in any animal during the course of the study. Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to male and female rats. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The acute dermal toxicity of the test material was determined in accordance with the standardised guidelines OECD 402, EU Method B.3 and EPA OPPTS 870.1200. Five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. Signs of slight irritation were seen in all animals but had completely resolved by day 14. All animals gained weight during the study. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to both male and female rats.
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