Ethyldimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl]ammonium ethyl sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): MADQUAT MC 75
- Physical state: liquid
- Analytical purity: 75.5%
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: M 67 bis
- Expiration date of the lot/batch: December 1995
- Stability under test conditions: stable
- Storage condition of test material: in the dark at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo (69210 L'Arbresle, France)
- Age at study initiation: : 8 weeks
- Weight at study initiation: 267 ± 12 g (males) and 219 ± 4 g (females)
- Fasting period before study:
- Housing: During acclimatisation: 4-7 by sex per cage, during observation: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2°C
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12.1.1995 To: 26.01.1995

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flank
- % coverage: approximately 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE: no
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Total volume applied: according to the body weight determined on the day of treatment and test substance specific gravity (1.104)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

10

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs, examined at least once a day
- Mortality: recorded at least twice a day
- Body weight: measured just before administration then on days 8 and 15.
- Necropsy of survivors performed: yes .
- macroscopic examination of the main organs: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious
abnormalities.
- microscopic examination: no

Statistics:

none

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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:

other: No clinical signs and cutaneous reactions were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the dermal LD50 of MADQUAT MC 75 in the rat is greater than 2000 mg/kg.