1-ethyl-1-methylpyrrolidinium bromide

Endpoint summary

Description of key information

Skin:

A 50% aqueous solution of the test substance was applied to intact skin of each of 3 rabbits.

Study was conducted according to OECD 404 and EC guideline 84/449 (method B4).

the animals were exposed for 4 hr and observations were done after 24, 48 and 72 hr after the end of exposure.

No toxic effects were noted. In animal 302 (#2) very slight erythema formation

Eye:

Mean scores for observations of the cornea, the iris and also for redness and for chemosis of the conjunctiva were "0" i.e normal in all animals

No general toxic effects were observed.

Therefore a 50% aqueous solution of the test substance is not irritant to eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July-November 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP and OECD guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Chemical nature: 50% aqueous solution of the test substance
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
Appearance: colourless liqiud

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

SOURCE ANIMAL
- Source: Charles River Wiga GmbH, Sandhofer Weg 7 D-8741 Sulzfeld
- Sex: 3 females
- Age at study initiation (in days): not mentioned
- Weight at study initiation: N0 310, 302, 303: 2.3 kg each
- Housing: individual caging in metal wire cages
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum.
- Water (e.g. ad libitum): tap water from an automatical watering system, ad libitum
- Acclimation period: 5 days

Type of coverage:

not specified

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

50% aqueous solution of the test substance was applied to the intact skin of each of 3 rabbits.

Duration of treatment / exposure:

exposure 4 hr

Observation period:

0, 24, 48 and 72 hr after end of exposure

Number of animals:

3 females

Details on study design:

Hair was clipped on the dorsal area of the trunk one day before the application of the test substance. An electric hair clipper, was used. The test site was median on the dorsal thoracal region. A cellulose patch with 0.5 gr of test substance spread over an area of approx. 6 cm2 was applied to the test site and held in place byfixing marginally with non irritating tape. The application site was prevented by a plastic collar. The duration of exposure was 4 hr. At the end of the exposure period the dressing, the tape with the patch and the collar were removed. residual test substance was wiped off using wet cellulose tissue.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal: #1, 2,3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Scores of 0 were noted at first skin observation for erythema formation and for oedema formation in all animals.
scores at reading times (24, 48 and 72 hr after the end of the exposure):
Erythema and eschar formation: only scores of 0, i.e normal scores, were observed in 2/3 animals at each reading time. In animal 302 (#2) very slight erythema formation (score 1) was noted 24 hr after exposure.
Oedema formation: In all animals only scores of 0, i/e normal scores, were noted at reading times.

Other effects:

No additional effects were noted

Interpretation of results:

GHS criteria not met

Conclusions:

50% aqueous solution of the test substance is not skin irritant

Executive summary:

A 50% aqueous solution of the test substance was applied to intact skin of each of 3 rabbits.

Study was conducted according to OECD 404 and EC guideline 84/449 (method B4).

the animals were exposed for 4 hr and observations were done after 24, 48 and 72 hr after the end of exposure.

No toxic effects were noted. In animal 302 (#2) very slight erythema formation (score 1) was noted 24 hr after exposure which was reversible.

Based on the study results, the test substance was found to be non irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 October - 27 October 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

N-Methyl-N-Ethyl-Pyrollidinium-bromid
50% aqueous solution
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
Colorless liquid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Supplier: Charles River Wiga GmBH, Sandhofer Weg 7, D-8741 Sulzfeld
number and sex: 3 females
body weight (on day of application):
animal No. 101: 2.6 kg; 102: 2.7 kg; 103 2.7 kg
Animal maintenance:
Hygiene: improved conventional conditions
Room number: PHA 16
Room temperature: average of 20°C
Relative humidity: average of 55%
Air exchange: 12/h
Light: artificial light from 6 am to 6 pm
Cages: individual caging in metal wire cages. Ehret Gmbh, D-7830 Emmendingen, type KK 016R, 79 X 59 cm X 35 cm.
Feed: Altromin 2023 diet for rabbits, ad libitum. Random samples of the food are analysed for contaminants by Altromin, D-4977 Lage.
Water: tap water from an automatical system, ad libitum.
Identification: labelling with felt-tipped pen in the ear.
Acclimatization: 12 days (animal No. 101) and 19 days (animals No. 102 and No. 103), respectively.

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml volume of the test substance (50% aqueous solution) was applied

Duration of treatment / exposure:

After application the eye was held closed for about 1 sec to prevent loss of test substance. the left eye was served as control

Observation period (in vivo):

Both eyes were examined within 24 hr before application and approx. 1, 24, 48 and 72 p.a. The entire eye, especially

Number of animals or in vitro replicates:

The test substance was applied first to one animal. Since there was no risk of serious damage to the eye of this animal noted after reading times, the test substance was applied to the other two animals to.

Details on study design:

The entire eye, especially cornea, iris and conjunctivae were examined, using an otoscope-lamp. Eye irritation /corrosion was scored.
According to the EC-guideline 91/325 a test substance is classified as irritant to the eye, if in 2/3 animals one of the following mean scores is obtained:
Cornea: 2 to <3
Iris: 1 to < 2
Conjuctiva, redness: 2.5 or more
Conjunctiva, chemosis: 2 or more

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: 1/24/48/72 hr

Score:

0

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: 1/24/48/72 hr

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

chemosis and redness

Basis:

animal: #1, #2, #3

Time point:

other: 1/24/48/72hr

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Mean scores for observations of the cornea, the iris and also for redness and for chemosis of the conjunctiva were "0" i.e normal in all animals
No general toxic effects were observed.

Therefore a 50% aqueous solution of the test substance is not irritant to eyes

Executive summary:

0.1 ml of a 50% aqueous solution of the test substance was applied to the cojunctival sac of one eye of each of 3 rabbits.

OECD 405 was applied, and observetions were made 1, 24 48 and 72 hr p.a

Mean scores for observations of the cornea, the iris and also for redness and for chemosis of the conjunctiva were "0" i.e normal in all animals

No general toxic effects were observed.

Therefore a 50% aqueous solution of the test substance is not irritant to eyes

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)