Registration Dossier
Registration Dossier
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EC number: 418-200-5 | CAS number: 69227-51-6
Skin irritation / corrosion
Administrative data
- 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
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 404 (Acute Dermal 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:
- 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
Test animals
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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