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Toxicological information

Skin irritation / corrosion

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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:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
other: mean at 24, 48 and 72h
Score:
1.78
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 8-15 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean at 24, 48 and 72h
Score:
1.44
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 8 days
Irritant / corrosive response data:
see table in attached document

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.