Registration Dossier
Registration Dossier
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EC number: 228-768-4 | CAS number: 6358-31-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 Feb - 16 Apr 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was performed in accordance with OECD and GLP guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- EC Number:
- 228-768-4
- EC Name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- Cas Number:
- 6358-31-2
- Molecular formula:
- C18H18N4O6
- IUPAC Name:
- 2-[(2-methoxy-4-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- - Name of test material (as cited in study report): Hansa Brilliant Yellow 5GX IN
- Common name: C.I. Pigment Yellow 74
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology Department Rallis Research Centre, Bangalore, India
- Age at study initiation: 4 months
- Weight at study initiation: 2.37-2.68 kg
- Housing: individually in fibreboard cages
- Diet (e.g. ad libitum): Amrut rabbit feed, Nav Maharashta Chakan Oil Mills Ltd, Pune, India, ad libitum
- Water (e.g. ad libitum): purified deep bore well water, ad libitum
- Acclimation period: 7-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 30-70 % relative humidity
- Air changes (per hr): adequate fresh air supply
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: paraffin oil
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, a paste was prepared with paraffin oil
- Treatment: On each animal, one patch with the test substance for every exposure period and one patch with the the vehicle alone were applied. - Duration of treatment / exposure:
- 3 minutes, 1 and 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm cotton gauze with test substance on it
- Type of wrap if used: Johnson-plast USP adhesive tape and crepe bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 3 minutes, 1 and 4 hours
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean of 3 animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects occurred
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects occurred
- Irritant / corrosive response data:
- No skin reactions were observed. At 1, 24, 48 and 72 hours erythema and edema scores were 0 for all three animals and all treatment periods.
- Other effects:
- No pre-terminal deaths were observed. Body weights of all the rabbits increased during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 67/548/EEC: Skin irritation: no classification warranted
1272/2008/EC: Skin irritation: no classification warranted
In a OECD guideline and GLP compliant skin irritation test in rabbits, Hansa Brilliant Yellow 5GX IN (Pigment Yellow 74) did not cause signs of skin irritation.
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