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Registration Dossier
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EC number: 281-468-5 | CAS number: 83950-14-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41 - Method of testing primary irritant substances.
- Principles of method if other than guideline:
- The exposure period was 24 hours.
A test on the abraded skin was included in the study design, but the results are not included in this summary - GLP compliance:
- no
Test material
- Reference substance name:
- 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate
- EC Number:
- 281-468-5
- EC Name:
- 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate
- Cas Number:
- 83950-14-5
- Molecular formula:
- C24H27N2O.C2H3O2
- IUPAC Name:
- 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippischen Versuchstierzucht Extertal
- Weight at study initiation: average 2.1 kg
- Housing: individual
- Diet: "Mümmel z" (SNIFF Soest Germany) ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days (observations after 30 min (=24 h), 48 and 72 hours and after 8 days)
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: occulsive (chirugical gaze covered with PVC foil kept in place with elastic bandage (Leukoflex and Eloflex)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
OBSERVATION TIME POINTS: 24, 48 and 72 hours and on day 8
SCORING SYSTEM:
- Method of calculation: similar to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- due to staining of the test site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1.83 - <= 2.17
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Indication of irritation which was reversible within 8 days in 2/6 rabbits
The averga oedema score in 2/6 rabbits was > 2.3 (see table) - Other effects:
- no other effects reported
Any other information on results incl. tables
| Animal no | 1 | 2 | 3 | |||||||||
| 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | |
| erythema | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| oedema | 2 | 2 | 2 | 2 | 1 | 0 | 2 | 2 | 1 | |||
| Animal no | 4 | 5 | 6 | |||||||||
| 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | 24 | 48 | 72 | 8 | |
| erythema | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| oedema | 3 | 2 | 2 | 3 | 3 | 2 | 1 | 1 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance is irritating to the skin
- Executive summary:
Six male rabbits were dermally exposed to the substance for 24 hours under occlusion. Erythema could not be scored due to staining of the skin. Based on the oedema scores the substance is considered to be irritating to the skin.
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