Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15/01/1992-29/01/1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study conducted to GLP.

Data source

Reference

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride

EC Number:

256-283-8

EC Name:

Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride

Cas Number:

46830-22-2

Molecular formula:

C14H20NO2.Cl

IUPAC Name:

benzyldimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride

Details on test material:

- Name of test material (as cited in study report): ADAMQUAT BZ 80
- Physical state: liquid
- Analytical purity: 78.5% in water
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 100%
- Purity test date: 06/12/1991
- Lot/batch No.: op 611/613/615/616
- Expiration date of the lot/batch: 12/1992
- 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: 264 ± 4 g (males) and 223 ± 4 g (females)
- Fasting period before study: yes
- Housing: groups of 4 to 7 animals of the same sex per cage during the acclimatization period and individually during the study.in sterilizable polycarbonate cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3"C
- Humidity (%): 50 ± 20% relative humidity
- Air changes (per hr): The air was non-recycled and filtered by absolute filters.
- Photoperiod (hrs dark / hrs light): 12 hours of light/12 hours of dark


IN-LIFE DATES: From: 15/01/1992 To: 29/01/1992

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: hydrophilic gauze patch

REMOVAL OF TEST SUBSTANCE : No

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg test substance/kg body weight
- Concentration (if solution): 2000 mg/kg
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

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 5, 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

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 mortalities were observed.

Clinical signs:

other: No clinical signs were observed during the study in 9/10 animals Hypokinesia and dyspnea were noted in one animal 24 hours after treatment. No clinical signs persisted thereafter. After removal of the dressing, a well-defined erythema was observed at th

Gross pathology:

Macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormality. Due to the absence of macroscopic lesions, no samples were taken for histological examinations.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of ADAMQUAT BZ 80 in rats was deyermined to be greater than 2000 mg/kg