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EC number: 265-449-9 | CAS number: 65113-55-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2012-03-06 to 2012-03-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- EC Number:
- 265-449-9
- EC Name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- Cas Number:
- 65113-55-5
- Molecular formula:
- C25H30N3.C18H14N3O3S
- IUPAC Name:
- [4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 13 to 14 weeks old
- Weight at study initiation: Between 2.73 and 3.10 kg
- Housing: individual box, installed in conventional air conditioned animal husbandry
- Diet (e.g. ad libitum): ad libitum (tap-water from public distribution system)
- Water (e.g. ad libitum): ad libitum (foodstuff SDS - C15)
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): From 30 to 70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g, moistened with distilled water - Duration of treatment / exposure:
- Exposure of 4 hours
- Observation period:
- Observation at 1 hour and then 24, 48 and 72 hours after removal of the patch.
- Number of animals:
- 1 animal initially and 2 other animals.
- Details on study design:
- TEST SITE
- Area of exposure: area of 6 cm² per patch. On the opposite flank an untreated area served as the control.
- Type of wrap if used: strip of surgical adhesive tape under semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the patch, rinsing with distilled water and liquid paraffin.
- Time after start of exposure: At the end of the exposure period, i.e after 4 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: A1886
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: A1888
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: A1886
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: A1888
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: A1890
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: A1890
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks:
- 24h = 1; 48h = 1
- Other effects:
- Yellow or slight blue coloration, not preventing local observations, noted on day 0 (at 1 hour post-dose) and remaining on day 3.
Any other information on results incl. tables
Individual skin reactions and average scores after 4 -hour exposure
OBSERVATIONS |
INDIVIDUAL DATA |
Total of individual data |
||||||
Skin reaction |
Observation time |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
|
A1886 |
Start: 2.73 |
A1888 |
Start: 2.79 |
A1890 |
Start: 2.93 |
|||
End: 2.66 |
End: 2.80 |
End: 3.10 |
||||||
|
1 hour (D0) |
0 |
0 |
1 |
1 |
|||
24 hours |
0 |
0 |
1 |
1 |
||||
48 hours |
0 |
0 |
1 |
1 |
||||
72 hours |
0 |
0 |
0 |
0 |
||||
Mean(24 to 72 hrs) |
0 |
0 |
0.7 |
/ |
||||
Oedema formation |
1 hour (D0) |
0 |
0 |
0 |
0 |
|||
24 hours |
0 |
0 |
0 |
0 |
||||
48 hours |
0 |
0 |
0 |
0 |
||||
72 hours |
0 |
0 |
0 |
0 |
||||
Mean(24 to 72 hrs) |
0 |
0 |
0 |
/ |
||||
Other reactions |
1 hour (D0) |
0² |
0³ |
0³ |
0 |
|||
24 hours |
0² |
0³ |
0³ |
0 |
||||
48 hours |
0² |
0³ |
0³ |
0 |
||||
72 hours |
0² |
0³ |
0³ |
0 |
||||
Mean(24 to 72 hrs) |
0 |
0 |
0 |
/ |
||||
²: Yellow coloration, not preventing local observations.
³: Slight blue coloration, not preventing local observations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result obtained, in these experimental conditions, enable to conclude that the test item must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statment is required. - Executive summary:
The test item was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established from the OECD guideline No. 404 dated April 24th, 2002 and the test method B.4 of the council regulation No. 440/2008 of 30 May 2008;
A very slight erythema was noted on the treated area of on animal, 1 hour after the patch removal and was totally reversible on day 3.
A sight yellow to blue coloration (not preventing erythema assessment ) was registered from the reading time 1 hour and remained on day 3 in all animals.
The results obtained, in these experimental conditions, enable to conclude that the test item not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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