Registration Dossier
Registration Dossier
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EC number: 219-470-5 | CAS number: 2440-22-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test performed according to proposed guideline, no details of test material purity. This substance differs in structure in a tertiary-butyl group in ortho position to the phenolic hydroxygroup and has a very similar toxicity profile. It is therefore considered adequate for read-across purposes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the US EPA 40CFR 163.81-5 'Primary dermal irritation study'
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- more stringent exposure conditions (24h onto abraded and non-abraded skin)
- GLP compliance:
- no
Test material
- Reference substance name:
- Bumetrizole
- EC Number:
- 223-445-4
- EC Name:
- Bumetrizole
- Cas Number:
- 3896-11-5
- Molecular formula:
- C17 H18 Cl N3 O
- IUPAC Name:
- 2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): TK 10048
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas, 7964 Kisslegg/Allgau, Germany; Madoerin AG, 4414 Fullinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): NAFAG No. 814 (Gossau AG) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55+/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 h dark/ 10 h light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: both sides shaved, one side abraded
- Vehicle:
- other: propylene glycol:saline (70:30)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 % w/w - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 6 (3 per sex)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage: no data
- Type of wrap if used: gauze patches covered with an impermeable material and fastened to the body with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
SCORING SYSTEM:
Skin reaction Value
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight
eschar formations (injuries in depth) 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by
definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter
and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1.16
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: At 48h, only one animal had an erythema. Values for non-abraded skin.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: values for non-abraded skin.
- Other effects:
- For abraded skin, almost identical scores were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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