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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:
guideline study
Remarks:
GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992
Reference Type:
publication
Title:
Atochem (1992), Acute Dermal Toxicity test in rats, CIT 8537 TAR
Author:
Atochem
Year:
2003
Bibliographic source:
cited in: OECD SIDS, 2-Dimethylaminoethylmethacrylate, CAS No: 2867-47-2, 07/2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
TEST MATERIAL:
- Name of test material (as cited in study report): Dimethylaminoethyl methacrylate (MADAME)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: ICO: OFA-SD (IOPS Caw)
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: mean males 255±3 g, mean females 228±8 g
- Housing: in groups of 4 to 7 of the same sex per cage in sterilizable polycarbonate cages (48 x 27 x 20 cm) during the acclimatization period and individually in sterilizable polycarbonate cages (35.5 x 23.5 x 19.3 cm) during the study
- Diet: certified pellet diet "Rats - Mice sustenance ref. A04 C" (U.A.R., 91360 Villemoisson-sur-Orge, France) ad libitum
- Water: filtered tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 50±20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The day before treatment, the dorsal area of each animal was clipped with an electric clipper on an area of 6 x 8 cm. Only animals with healthy intact skin were used for the study. The TS in its original form was applied at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity (SG) of the TS was 0.933 directly to an area of skin representing approximately 10% (5 x 6 cm for the females and 5 x 7 cm for the males) of the body surface of the animal. This was calculated according to Meeh's formula (AFNOR-TO3-23 Standard, August 1980, France). A hydrophilic gauze patch was then applied to the skin. The TS and the gauze patch were held in contact with the skin for 24 hours by means of an adhesive hypoallergic aerated semi-occlusive dressing attached to a restraining bandage. This dressing prevented the ingestion of the TS by the animal. No residual TS was observed at removal of the dressing.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: The body weight gain of the treated animals was compared to a reference curve of the C.I.T. control animals with the same initial weight.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was checked frequently just after application of the TS and then at least twice a day during the 14-day observation period. The animals were observed for clinical signs frequently after application of the TS and at least once a day during the observation period. The animals were individually weighed just before application of the TS and then on days 5, 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occured at the dose level of 2000 mg/kg.
Clinical signs:
Within 72 hrs of application of the test substance, hypokinesia, sedation and dyspnea were observed and had reversed on day 5. Local signs of marked irritations were noted during the study.
Body weight:
The body weight gain of the animals was not influenced by the treatment.
Gross pathology:
The macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study. Signs of cutaneous irritation had eversed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test substance administered by dermal route in rats is higher than 2000 mg/kg.
Executive summary:

The LD50 of the test substance administered by dermal route in rats is higher than 2000 mg/kg.