Registration Dossier
Registration Dossier
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EC number: 205-769-8 | CAS number: 150-76-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2006-06-20 to 2006-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study following the guidelines without any deviations, performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Mequinol
- EC Number:
- 205-769-8
- EC Name:
- Mequinol
- Cas Number:
- 150-76-5
- Molecular formula:
- C7H8O2
- IUPAC Name:
- 4-methoxyphenol
- Details on test material:
- Test material identity: paramethoxyphenol (PMP)
Details on test material:
* Substance type: pure active substance
* Analytical purity: 99.55%
* Impurities: hydroquinone (<0.01%), paradimethoxybenzene (0.06%), water (0.09%)
* Purity test date: 29-MAY-2006
* Lot/batch No: FMP0611901
* Expiration date of the lot/batch: 28-APR-2007
* Stability under test conditions: data not available
* Storage condition of test material: at room temperature, protected from light, moisture and air
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: COMMON SPECIES: rabbit
- Strain: RABBIT STRAINS: New Zealand White
- Source: CEGAV breeding establishment - Les Hautes Noës, Saint Mars d'Egrenne, 61350 Passais la Conception, France
- Age at study initiation: between 9 and 18 weeks
- Weight at study initiation: between 3.9 and 4.8 kg
- Housing: individually in cages of standard cage (635.435.335 mm)
- Diet: SDS/DIETREX STANRAB (P) SQC feed was distributed daily at fixed times
- Water: ad libitum
- Acclimation period: for at least 5 days before the treatment
ENVIRONMENTAL CONDITIONS:
- Temperature: 17 - 21°C
- Humidity: 45 - 65%
- Air changes: approx. 10 times per hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 20-JUN-2006 to 11-JUL-2006
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: adjacent surface of non-treated skin of each animal served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data
- VEHICLE:
* Amount applied: sufficiently in order to allow good contact between the test item and the skin
* Purity: sterile water - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE:
- Area of exposure: 6 cm²
- % coverage: data not available
- Type of wrap if used: the gauze square was protected by a pad consisting of a semi-occlusive micro-porous and non-allergic dressing and held in place with a supple and aerated fastening system consisting of elastic, adhesive and hypoallergenic tape
REMOVAL OF TEST SUBSTANCE:
- Washing: no (no residual test item was noted at the end of the exposure period)
SCORING SYSTEM: in accordance with OECD guideline No. 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 8-15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8-15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8-15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8-15 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.44
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- see table in attached document
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: not irritating according to the Directive 67/548/EEC criteria, and to the EU CLP Regulation (EC) n°1272/2008.
- Executive summary:
In a primary dermal irritation study (Freulon I, 2006), young adult New Zealand White rabbits (3 animals) were dermally exposed to 0.5 g of PARAMETHOXYPHENOL (99.55% purity) moistened with water for 4 hours to an area of 6 cm². Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 14 days. Irritation was scored in accordance with OECD guideline 404.
In this study, PARAMETHOXYPHENOL is slightly irritating to the skin, according to the annex IV of the Directive 67/548/EEC.
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