1-ethyl-1-methylpyrrolidinium bromide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July-December 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study done under GLP and OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-ethyl-1-methylpyrrolidinium bromide

EC Number:

418-200-5

EC Name:

1-ethyl-1-methylpyrrolidinium bromide

Cas Number:

69227-51-6

Molecular formula:

C7H16NBr

IUPAC Name:

1-ethyl-1-methylpyrrolidin-1-ium bromide

Specific details on test material used for the study:

Cas # 69227-51-6
Batch # 0691
pH: 6-9
Storage: 5°C in the dark
Supplier: Chemson, Polymer-Additive Gesellschaft m.b.H. A-9601 Arnoldstein.
Characterization:
Appearance: Colorless liquid.
pH 6.84
Content 52.2% (estimation of bromide)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Him: OFA

Sex:

male/female

Details on test animals or test system and environmental conditions:

Supplier: Forscungsinstitute fur Versuchstierzucht, A-2325 Himbera.
Number in the study: 5 males and 5 females
Age: approx. 8 weeks (males) and 12 weeks (females) at time of administration.
Body weight: 245 gr (mean, males), 230 (mean, females)
Hygiene: imporoved conventional conditions
room temperature: average of 12 °C.
Relative humidity: average of 55%
Air exchange 12 / h
Light: artificial light from 6 am to 6 pm
Cages: single caging in Makrolon cages type III . Wire mesh lids.
Bedding material: Aspen wood chips, autoclaved
Feed: Altromin No. 1314 ff, gamma irradiated with 10 kGy 60Co, ad libitum.
Water: tap water, offered in Makrolon bottles with stainless steel canules, ad libitum.
Acclimatization: 7 days

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dermal administration was performed once in the morning by spreading the test substance over an area of approx. 5 cm x 6 cm which is at least 10% of the body surface.
Hair was clipped one day before the application with an electric hair clipper. The test site was median on the dorsal thoracal region.
The administrated test substance was covered by cellulose patch and held in place by non irritating tape. Patch and tape were covered by a dressing.

Duration of exposure:

The duration of the exposure was 24 hr
At the end of the exposure period the dressing the tape and the patch were removed. residual test substance was wiped off using wet cellulose tissue.

Doses:

2000 mg/kg b.w

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Behaviour, reactions and physical signs of the animals were observed 10, 30 min, 1, 2, 4 and 6 hr after administration (p.a) and then at least once a day for a total of 2 weeks. Body weight was determined before administration, 7 days p.a. and 14 days p.a.
All animles were sacrificed by CO23 14 days p.a. and examined macroscopically in an attempt to detect possible residual lesions.

Statistics:

n/a

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality

Body weight:

Body weight and body weight gain were inconspicuous in all males and in 2/5 females. In the other females a body weight loss respectively a lower body weight gain as compared to untreated animals of the same strain were noted.

Other findings:

3/10 animls were normal during the whole observation time. All males and 2/5 females chromodacryorrhoea, a sign of general malase, was observed within maximium 4 hr p.a. and is attributed to a reduced wellbeing caused by the dressing. Salivation, noted in one male, is not regarded as important due to single and short occurrence.
8/10 animles were normal at terminal necropsy.
A large spleen, noted in two females, is regarded as incidental finding without toxicological importance.
No sex diffences were noted except for body weight gain which was lowered in some females.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All animles survived until termination.
No toxicological signs were observed during the test and obervations which were noted were not of toxicological importance.
Therefore LD50 of the test substance was > 2000 mg/kg b.w

Executive summary:

A 50% solution of the test substance was administered once dermally to 5 males and 5 females (Him:OFA rats) (OECD 402).

The test substance was applied at a dose of 2000 mg/kg. the duration of the exposure was 24 hr and the study terminated after 14 days.

All animals survuved until the end of the study.

No toxicological signs were observed during the test and  obervations which were  noted were not of toxicological importance.

Therefore LD50 of the test substance was > 2000 mg/kg b.w