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Toxicological information

Acute Toxicity: dermal

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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:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
None
Body weight:
Between days 1 and 5, a decrease in body weight in one male (N°05) was noted without subsequent consequence, probably due to stress caused by the experimental conditions.
Gross pathology:
No apparent abnormalities

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008
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.