Registration Dossier
Registration Dossier
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EC number: 209-940-8 | CAS number: 598-56-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, OECD n°402 Guideline (1987, February 24th)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyldimethylamine
- EC Number:
- 209-940-8
- EC Name:
- Ethyldimethylamine
- Cas Number:
- 598-56-1
- Molecular formula:
- C4H11N
- IUPAC Name:
- ethyldimethylamine
- Details on test material:
- - Supplier: Elf-Atochem
- Name of test material (as cited in study report): Dimethylethylamine (DMEA)
- Physical state: liquid
- Analytical purity: 99.078%
- Purity test date: 1992-06-30
- Lot/batch No.: 9206P0513
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: in dark at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague Dawley rats ICO: OFA-SD (IOPS Caw) supplied by Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 280+/-5g (males) and 214+/-8g (females)
- Fasting period before study: no
- Housing: individually in plycarbonate cages (35.5x23.5x19.3cm)
- Diet (e.g. ad libitum): ad libitum certified pelleted diet "rats - Mice sustenance ref.A04C" (U.A.R. 91360 Villemoisson sur Orge, France)
- Water (e.g. ad libitum): ad libitum drinkin water filtered by a 0.22µ fliter membrane (Société Millipore, 78140 Vélizy, France)
- Acclimation period: 5days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 1992-10-21 (sacrifice)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6x8cm
- % coverage: approx. 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi occlusive dressing (Laboratoires de Pansements et d'Hygiène, 21300 Chenove, France) attached to a restraining bandage (Laboratoires 3M, 92245 Malakoff, France)
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg taking in consideration that the specific gravity of the substance was 0.675 - Duration of exposure:
- 24hours
- Doses:
- 2000mg/kg (specific gravity=0.675)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs recorded frequently after application and then once daily, mortality checked twice daily, animals weighted on days 1, 5, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No death
- Clinical signs:
- other: None
- Gross pathology:
- No apparent abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD0 by dermal application in rats of the test item Dimethylethylamine is higher than 2000mg/kg.
- Executive summary:
The Acute dermal toxicity of Dimethylethylamine (DMEA) was evaluated in male and female Sprague Dawley rats according to OECD N°402 guideline.
Ten rats were applied dermally 2000mg/kg for 24hours and then observed during 14days. No control group was used.
Neither death nor clinical signs were recorded during the study showing that under these experimental conditions, the dermal LD0 of DMEA is higher than 2000 mg/kg in rats.
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