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EC number: 276-696-7 | CAS number: 72490-01-8
- 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:
- Jun/Jul 1980 to Sep/Oct 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
- EC Number:
- 276-696-7
- EC Name:
- Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
- Cas Number:
- 72490-01-8
- Molecular formula:
- C17 H19 N O4
- IUPAC Name:
- ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult : 7 – 9 weeks
- Weight at study initiation: 195 – 263 g
- Housing: singly in metal cages with wire mesh floors.
- Diet: standard laboratory rodent diet, ad libitum.
- Water: provided, ad libitum.
- Acclimation period: at least 3 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 25
- Humidity (%): 51 (mean)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: Jun/Jul 1980 To: Sep/Oct 1980
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 % of the total body surface
- Type of wrap if used: The treated area was covered with aluminium foil held in place with an impermeable dressing encircled firmly round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: After 24 hours, the dressings were removed and treated area was washed with warm (40 – 50 °C) water and finally blotting dry with absorbent paper.
TEST MATERIAL
- Amount applied: not exceeding 5 mL/kg
- Concentration: 40 % w/v test substance suspended in corn oil
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw (Study 1 and 2)
- No. of animals per sex per dose:
- 5 (Study 1 and 2)
- Control animals:
- yes, concurrent vehicle
- Remarks:
- Only study 1
- Details on study design:
- TEST PROCEDURE/ DESIGN:
- Study 1: A group of 5 male and 5 female rats was treated at 2000 mg/kg which was considered to be the maximum practical dose. A vehicle control group of 5 male and 5 female rats was treated with corn oil at the same dose volume as the test group.
- Study 2: A further 5 male (numbered 1 to 5 inclusive) and 5 female (numbered 6 to 10 inclusive) rats were treated at 2000 mg/kg in order to provide tissues for histopathological examination.
- Duration of observation period following administration: 14 days.
- Frequency of weighing: Individual body weights of the animals were recorded on Days 1, 8 and 15.
- Frequency of observations: Animals were observed immediately after dosing and at approximately intervals for the remainder of Day 1. On Day 2 the animals were observed once in the morning and once at the end of the experimental day. On subsequent days the animals were observed once in the morning and once at the end of the experimental day (Study 2) or once daily (Study 1).
- Necropsy of survivors performed: yes, on Day 15 and were subjected to a macroscopic post mortem examination. The macroscopic appearance of abnormal organs was recorded.
- Clinical signs: Clinical signs were recorded at each observation time. The nature, severity, approximate time of onset and duration of each toxic sign. Local dermal reactions were recorded 24 hours after application of the test material and daily thereafter. The dermal reactions were assessed on a numerical basis according to the arbitrary scoring system as mentioned in Table 1 of' Any other information on materials and methods incl. tables'.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in either study.
- Clinical signs:
- other: In Study 1, there was no observable dermal irritation at the site of application in either the treated or control animals. In Study 2, 5/10 test substance exposed rats showed lethargy, and 1/10 showed decreased respiratory rate. There was no dermal irrita
- Gross pathology:
- Histopathology on study 2 animals showed small focal areas of epidermal ulceration with an associated acute inflammatory cell infiltration into the superficial dermis in the treated skin area of 2 females.
All animals showed minimal mononuclear cell aggregations and/or occasional foci of extramedullary haemopoiesis in the liver. 4/10 rats showed minor lesions in the kidneys.
Terminal autopsy findings were considered to be within normal limits.
Any other information on results incl. tables
Table 2 Mortality ratio, and group mean body weights (g) of rats dosed percutaneously with test substance
(Study 1)
Sex |
Dosage (g/kg) |
Body Weight (g) at |
Mortality ratio (No of deaths)/No dosed) |
||
Dosing |
1 week |
2 weeks |
|||
males |
0 |
250 |
291 |
340 |
0/5 |
241 |
279 |
334 |
|||
238 |
285 |
334 |
|||
251 |
286 |
332 |
|||
Mean |
247 |
284 |
333 |
||
2.0 |
234 |
263 |
299 |
0/5 |
|
240 |
285 |
331 |
|||
253 |
302 |
361 |
|||
228 |
277 |
322 |
|||
245 |
275 |
305 |
|||
Mean |
240 |
280 |
324 |
||
females |
0 |
222 |
239 |
279 |
0/5 |
244 |
262 |
281 |
|||
248 |
265 |
300 |
|||
227 |
240 |
261 |
|||
Mean |
236 |
253 |
281 |
||
2.0 |
230 |
244 |
271 |
0/5 |
|
221 |
234 |
258 |
|||
242 |
259 |
272 |
|||
232 |
246 |
271 |
|||
223 |
247 |
272 |
|||
Mean |
230 |
246 |
269 |
Table 3 Mortality ratio, and group mean body weights (g) of rats dosed percutaneously with test substance
(Study 2)
Sex |
Dosage (g/kg) |
Body weight at |
Mortality ratio (no of deaths / no dosed) |
||
Dosing |
1 week |
2 weeks |
|||
males |
2.0 |
240 |
270 |
299 |
0/5 |
263 |
309 |
360 |
|||
251 |
300 |
344 |
|||
248 |
290 |
326 |
|||
246 |
296 |
341 |
|||
Mean |
250 |
293 |
334 |
|
|
females |
2.0 |
212 |
218 |
241 |
0/5 |
205 |
219 |
229 |
|||
216 |
231 |
250 |
|||
200 |
208 |
209 |
|||
214 |
228 |
236 |
|||
Mean |
209 |
221 |
233 |
|
Table 4 Signs of reaction to treatment ratio of rats percutaneously with test substance
(Study 2)
Signs |
Signs of reaction ratio (No showing signs/ No. dosed) |
Dose (g/kg) |
|
2.0 |
|
Lethargy Decreased respiratory rate |
5/10 1/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute median lethal percutaneous dose (LD50) to rats of test substance was found to be greater than 2000 mg/kg bw which was considered to be the maximum practical dosage under the conditions of this test.
- Executive summary:
An acute dermal study was performed in accordance with OECD TG 402 following GLP principles. The test was conducted with Sprague-Dawley derived rats to determine the potential for the test substance to produce toxicity from a single topical application. Two studies were performed; the first (Study 1) include a group of 5 male and 5 female rats was treated at 2000 mg/kg which was considered to be the maximum practical dose. A vehicle control group of 5 male and 5 female rats was treated with corn oil at the same dose volume as the test group. In a second study (Study 2) a further 5 male and 5 female rats were treated at 2000 mg/kg in order to provide tissues for histopathological examination. Animals were observed immediately after dosing and at approximately intervals for the remainder of Day 1. On Day 2 the animals were observed once in the morning and once at the end of the experimental day. On subsequent days the animals were observed once in the morning and once at the end of the experimental day (Study 2) or once daily (Study 1).
No mortality was observed. From Study 2, 5/10 rats showed lethargy, and 1/10 showed decreased respiratory rate. In Study 1, no effects on body weight gain were observed. In Study 2, 2/5 females showed a decreased body weight gain during the first week, and 3/5 females during the second week, compared to the controls of Study 1. Histopathology on Study 2 animals showed small focal areas of epidermal ulceration with an associated acute inflammatory cell infiltration into the superficial dermis in the treated skin area of 2 females. All animals showed minimal mononuclear cell aggregations and/or occasional foci of extramedullary haemopoiesis in the liver. 4/10 rats showed minor lesions in the kidneys.
The LD50 of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg bw which was considered to be the maximum practical dosage under the conditions of this test.
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