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EC number: 270-128-1 | CAS number: 68411-46-1
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.1.-24.1.1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP (performed 1988), OECD conform, 3 animals used, observation period 7 days even if effects still visible, no autopsy
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene
- EC Number:
- 270-128-1
- EC Name:
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene
- Cas Number:
- 68411-46-1
- Molecular formula:
- C16H19N - C28H43N (main constituents)
- IUPAC Name:
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Measured for Batch: Density 0.976 g/ml; refraction index (20°C) = 1.571; nitrogen content 4.6%; further components quantified by gas chromatography
Constituent 1
- Specific details on test material used for the study:
- - Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum.
- Water: ad libitum
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back
- coverage: at least 6 sq. cm
- Type of wrap if used: non-irritating adhesive tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1,24,48,72 h and 7 d
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- EC 270-128-1 was found to be slightly irritant to skin, scores are below the threshold for classification and labelling as an irritant in the European Union which has not implemented GHS category 3 for skin irritation.
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