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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC (OJ No L251)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[2-(acryloyloxy)ethyl]trimethylammonium chloride
EC Number:
256-176-6
EC Name:
[2-(acryloyloxy)ethyl]trimethylammonium chloride
Cas Number:
44992-01-0
Molecular formula:
C8H16NO2.Cl
IUPAC Name:
Trimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride
Details on test material:
Test substance: other TS: ADAMQUAT MC 80
Source: Norsolor
Batch number: no data
Purity: no data
Other: Test substance was supplied as an 80% aqueous solution.

Test animals

Species:
rat
Strain:
other: CD [Crl: CD (SD) BR VAF plus]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK (Margate, Kent, UK)
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 200 - 300 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: occlusive
- % coverage: 10%
REMOVAL OF TEST SUBSTANCE
- Washing (if done): area of skin was washed with warm water (30-40°C) and then blotted dry with absorbent paper
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.75 ml/kg bw
- Concentration (if solution): as supplied: 80% in water
Duration of exposure:
24 hours
Doses:
2000 mg/kg (2000 g of 80% solution / kg bw)
Total volume applied: 1.75 ml/kg, according to the body weight determined on the day of treatment and test substance specific gravity (1.14)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Observations:
-Clinical signs: examined at least once a day;
-Mortality: recorded at least once a day
- Body weight: measured just before administration then on days 8 and 15.
- Necropsy:
- macroscopic examination of the main organs of the abdominal and thoracic cavities.
- microscopic examination: no
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No systemic effects were observed. Dose site irritation included slight erythema in all male rats on day 2 and slight to moderate erythema with slight to well-defined oedema among females from day 2 to day 7; the irritation for one female was limited to small areas of the dose site on days 3 and 4. Spots on the dose site were also observed in the majority of rats on days 3 and 4. These reactions developed into scabs. However, the skins of all animals appeared normal by day 11.
Body weight:
Slightly low bodyweight gains were recorded for one male on day 8 and for one female on day 15. All other animals achieved anticipated bodyweight gains throughout the study
Gross pathology:
No macroscopic abnormalities were revealed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute LD0 (and LD50) of ADAMQUAT MC in the rat was determined to be greater than 2000 mg/kg body weight by the dermal route.