Registration Dossier
Registration Dossier
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EC number: 210-323-0 | CAS number: 612-83-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed study, test procedure in accordance with existing guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,3'-dichlorobenzidine dihydrochloride
- EC Number:
- 210-323-0
- EC Name:
- 3,3'-dichlorobenzidine dihydrochloride
- Cas Number:
- 612-83-9
- Molecular formula:
- C12H10Cl2N2.2ClH
- IUPAC Name:
- 3,3'-dichloro-[1,1'-biphenyl]-4,4'-diamine dihydrochloride
- Details on test material:
- - Name of test material (as cited in study report): 3,3'-dichlorobenzidine dihydrochloride
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: singly housed in suspended stainless steel cages
- Diet: Purina Rabbit Chow #5326, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g (dry weight basis)
- Concentration (if solution): 70% w/w (dry aqueous paste) - Duration of treatment / exposure:
- 3 minutes, 1 hour, 4 hours, the sites were then gently wiped with water
- Observation period:
- - all sites were examined 1 hour after patch removal
- all sites were examined 24, 48 and 7 hours after removal of the 4-hour patch - Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 square centimetre
- Type of wrap if used: covered with a 1"x1" 4-ply gauze pad, wrapped with 3" Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing: wiped with water and a clean towel
- Time after start of exposure: 3 minutes, 1 or 4 hours
SCORING SYSTEM:
Evaluation of Skin reactions:
Erythema and eschar formation:
0: no erythema
1: very slight erythema (barely perceptible)
2: well defined erythema
3: moderate to severe erythema
4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema formation:
0: no edema
1: very slight edema (barely perceptible)
2: slight edema (raised approximately 1 millimeter)
3: moderate edema (raised approximately 1 millimeter)
4: severe edema (raised more than 1 millimeter and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animal # 4349, 4350, 4351 each
- Time point:
- other: mean of 24, 48, and 72 hours
- Score:
- 0
- Reversibility:
- other: no signs of irritation at any time
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- other: animal # 4349, 4350, 4351 each
- Time point:
- other: mean of 24, 48, and 72 hours
- Score:
- 0
- Reversibility:
- other: initial slight effects were fully reversible within 24 hours
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- other: animal # 4349, 4351 each
- Time point:
- other: mean of 24, 48, and 72 hours
- Score:
- 0
- Reversibility:
- other: no signs of irritation at any time
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- other: animal # 4350
- Time point:
- other: mean of 24, 48, and 72 hours
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- other: animal # 4349, 4350, 4351 each
- Time point:
- other: mean of 24, 48, and 72 hours
- Score:
- 0
- Reversibility:
- other: no signs of irritation at any time
- Remarks on result:
- other: 3min, 1 or 4 hours exposure each
- Irritant / corrosive response data:
- No corrosion (full-thickness necrosis of the dose site) was observed in any animal one hour after 3 minutes, 1 and 4 hour exposure.
No edema was observed in any animal after 4 hour exposure at the indicated observation time points.
One animal showed very slight erythema (value 1 of the scoring system) one hour after removing the 1 hour patch and one and 24 hours after removing the 4 hour patch (for details see below).
Any other information on results incl. tables
Primary skin irritation scores erytheme/edema (3 minutes exposure)
1 hour after patch removal |
Hours after removal of 4-hour patch |
||||
Animal No. |
Sex |
24 |
48 |
72 |
|
4349 |
M |
0/0 |
0/0 |
0/0 |
0/0 |
4350 |
M |
0/0 |
0/0 |
0/0 |
0/0 |
4351 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
Primary skin irritation scores erythema/edema (1 hour exposure)
1 hour after patch removal |
Hours after removal of 4-hour patch |
||||
Animal No. |
Sex |
24 |
48 |
72 |
|
4349 |
M |
0/0 |
0/0 |
0/0 |
0/0 |
4350 |
M |
1/0 |
0/0 |
0/0 |
0/0 |
4351 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
Primary skin irritation scores erythema/edema (4 hours exposure)
Hours after removal of patch |
|||||
Animal No. |
Sex |
1 |
24 |
48 |
72 |
4349 |
M |
0/0 |
0/0 |
0/0 |
0/0 |
4350 |
M |
1/0 |
1/0 |
0/0 |
0/0 |
4351 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item is not corrosive and not irritating to the skin.
- Executive summary:
Acute dermal irritation and corrosion have been investigated in three New Zealand rabbits in a test which is in agreement with existing guidelines. There were no signs of corrosion observed. Edema did not occure in any animal. Only one rabbit showed very slight erythema one and 24 hours after removal of the four hour patch and one hour after removal of the 1 hour patch. These effects were fully reversible within the 72 hours observation period.
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