Registration Dossier
Registration Dossier
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EC number: 214-160-6 | CAS number: 1103-38-4
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- information to test substance (purity) not given
- GLP compliance:
- no
Test material
- Reference substance name:
- Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]
- EC Number:
- 214-160-6
- EC Name:
- Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]
- Cas Number:
- 1103-38-4
- Molecular formula:
- C20H14N2O4S.1/2Ba
- IUPAC Name:
- barium(2+) bis(2-[(1E)-2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]naphthalene-1-sulfonate)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight (kg) at study initiation: 2.22 male and 2.28 female
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10h light period
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and right hand site abraded
- Vehicle:
- other: 50% aqueous solution of polyethylene glycol
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g or 1.5 ml
VEHICLE 50% PEG
- Amount(s) applied (volume or weight with unit): 1.5 ml applied on a 2.5 cm2 gauze pad
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 24h
- Observation period:
- after 24 and 72h
- Number of animals:
- 3 per sex
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.83
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded and intact skin
- Irritant / corrosive response data:
- A very slight to slight oedema was seen in 5/6 intact and abraded sites 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 0.5.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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