Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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: Guideline study

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)
GLP compliance:
yes
Remarks:
Centre International de Toxicolgoie, France
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6 DCPTFMA
- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle. France
- Age at study initiation: about 8 weeks old
- Weight at study initiation: mean: 270 ± 7 g for the males and 219 ± 9 g for the females
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Vehicle:
TEST SITE
- Area of exposure: 5 x 6 cm for the females and 5 x 7 cm for the males
- % coverage: about 10% of the body surface
- Type of wrap if used: hydrophilic gauze patch (Semes France, 54183 Heille-Court, France)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test substance was observed at removal of the dressing.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- For solids, paste formed: yes: test substance was premoistered with 2 ml water for injection
Duration of exposure:
24 hours
Doses:
2000mg/kg
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the observation period.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
Between days 1 and 5, a decrease in body weight was noted for one female (No. 02). This finding was probably due to the stress caused by the
experimental conditions and was not attributed to the treatment with the test substance. The body weight of this animal showed an improvement
during the remainder of the observation period. The body weight gain of the other animals was normal.
Gross pathology:
Macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities. Due to the absence of macroscopic lesions, no samples were taken for histological examinations.

Applicant's summary and conclusion