Registration Dossier
Registration Dossier
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EC number: 213-888-1 | CAS number: 1052-38-6
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: Study following official guideline in GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- 4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine
- EC Number:
- 213-888-1
- EC Name:
- 4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine
- Cas Number:
- 1052-38-6
- Molecular formula:
- C18H18N8
- IUPAC Name:
- 4,4'-(1E,1'E)-1,3-phenylenebis(diazene-2,1-diyl)dibenzene-1,3-diamine
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton, Huntingdon, England
- Weight at study initiation: the animals were weighed immediately before application of the test substance
- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or polyethyelene cages with perforated bases. Excrement trays beneath the cages contained low-dust (wood) bedding . Bedding was regularly spotted for contaminants and changed at least twice weekly.All the animals were kept in one room
- Diet (e.g. ad libitum): standard diet "Saniff K4" approx. 100-120 g per animal/day, once per day in the morning
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: the animals were kept for at least 14 days in the quarantine station and monitored for diseases. During this period pooled faeces specimens were examined for coccidia oocysts
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50%
- Air changes (per hr): apporx. 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 to 18 hrs CET time
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral skin area not treated with test substance served as control
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h, 7d, 14d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm square
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposed skin areas were carefully washed with wtaer without altering the existing responses
SCORING SYSTEM: draize score at 24, 48 and 72h and the total of these three values was divided by 3 to give the irritation index. This index was separately calculated for erythema/eschar formation and for oedema formation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (draize score)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- (draize score)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- (draize score)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- (draize score)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- (draize score)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- (draize score)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- The substance was tested for skin irritation following OECD 404. Under the test conditions the substance did not show irritating properties.
- Executive summary:
The substance was tested for skin irritation following OECD 404. Three New Zealand White rabbits were exposed to the test item in a semi-occlusive patch for 4 hours after clipping the lateral area of the dorso. Skin effects like oedema and erythema were checked and the mean values at 24,48 and 72h were calculated and resulted equal to zero for the three animals. Under the experimental conditions the substance is not considered as skin irritant.
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