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Registration Dossier
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EC number: 418-200-5 | CAS number: 69227-51-6
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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
Constituent 1
- 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
Test animals / tissue source
- 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.
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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
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