Registration Dossier
Registration Dossier
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EC number: 255-578-9 | CAS number: 41892-01-7
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test includes both intact and abraded skin and is occlusve rather than semi-occlusive
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
- EC Number:
- 255-578-9
- EC Name:
- (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
- Cas Number:
- 41892-01-7
- Molecular formula:
- C17H37ClNO.Cl
- IUPAC Name:
- (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: ca. 11 months
- Weight at study initiation: 2.7 - 2.9 kg
- Housing: 1 animal / cage. Laboratory and cage cleaning by means of standard antiseptics, instrument and device disinfection by autoclave and hot air sterilizer
- Water : add libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 1°C
- Humidity (%): 50 - 60 %
- Photoperiod: 12 hours (fluorescent lighting) / 12 hours (darkness)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact or abraded skin
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml of the test product
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1; 24; 48; 72 hours after the treatment
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- mean
- Remarks:
- Scarified skin
- Time point:
- 24/48/72 h
- Score:
- 1 - <= 2
- Reversibility:
- fully reversible within: 5 to 6 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- Scarified skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1 - <= 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin districts
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin districts
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin districts
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1 - < 2
- Reversibility:
- fully reversible
- Remarks:
- 11 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.17
- Max. score:
- 8
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The erythema in the intact skin areas scored between 1 and 2 (very light and well-defined erythema). These occurred between 1 and 24 hours after removal of the dressing and were detectable up to a maximum of 11 days thereafter. In the abraded regions erythema of strength 1 to 3 (very mild to moderate / severe erythema) occurred. They were detectable beyond the 14-day observation period. From the 6th observation day, there was a formation of scabs in the area of exposure sites. The scabs disappeared after 14 to 22 days, so that the repair process could begin with the irritated skin areas under scarring.
The oedema only had a low intensity (assessment number 1) at the intact skin districts. One animal remained without oedema. These findings were detectable in the intact regions on the fifth day of observation. Oedema of grades 1 and 2 were found in the abraded regions (very light and mild oedema). These findings were also not detectable for more than 5 to 6 days.
Any other information on results incl. tables
The results were assessed against the following index:
0.0 - 0.5 No irritation
0.6 - 3.0 Light irritation
3.1 - 5.0 Moderate irritation
5.1 - 8.0 Strong irritation
The test substance was given a score of 3.17, moderate irritant
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The report's assesment of the results determined that the test substance was a 'Moderate Irritant'
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