Registration Dossier
Registration Dossier
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EC number: 201-240-0 | CAS number: 79-97-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Jul - 16 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in Apr 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-isopropylidenedi-o-cresol
- EC Number:
- 201-240-0
- EC Name:
- 4,4'-isopropylidenedi-o-cresol
- Cas Number:
- 79-97-0
- Molecular formula:
- C17H20O2
- IUPAC Name:
- 4,4'-isopropylidenedi-o-cresol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white species (Kbs:JW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ina Breeding Center, Kitayama Labes, Co., Ltd., Nagano, Japan
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.71 - 2.38 kg
- Housing: The animals were individually housed in aluminium cages (W350 x D550 x H350 mm) in stainless-steel automatic-washing racks.
- Diet: pelleted diet RC4 (Lot. No. 160330, 160414 from Oriental Yeast Co., Ltd.), 150 g/day
- Water: municipal tap water, ad libitum
- Acclimation period: 8 - 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 25.9
- Humidity (%): 48.2 - 65.4
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 19 Jul 2016 To: 23 Jul 2016
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped and thereafter shaved
- Vehicle:
- other: olive oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: 0.5 mL olive oil was dropped and blended well with the test substance. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the dorsal area of the drunk
REMOVAL OF TEST SUBSTANCE
- After patch removal, the test substance remaining on the skin was removed as much as possible (not further specified)
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No skin reaction was observed on the skin in any rabbit after 24, 48 and 72 h of observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits.
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