Registration Dossier

Administrative data

Description of key information

PMP is officially classified as irritant for eyes according to CLP Regulation n°1272/2008 Annex VI tables 3.1 and 3.2.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

One study was chosen as key study, of reliability 1 (CERB, 2006). In this primary dermal irritation study, 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. (mean scores: 1.78 and 1.44 for erythema and edema respectively). In this study, PMP is slightly irritating to the skin.

Two other studies of reliability 3 are referenced, but they are not suffliciently described to permit conclusions.

Official classification: PMP is not officially classified for this endpoint, according to EU CLP Regulation n° 1272/2008 Annex VI tables 3.1 and 3.2, for skin irritation.

Eye irritation:

One study of reliability 3 (Dow chemical report, 1959) cannot permit a conclusion, and one study of reliability 4 (secondary reference), which led to a conclusion of highly irritating. Based on these two studies, it is not possible to classify PMP for eye irritation.

PMP is however officially classified as Xi, R36 according to the EU CLP Regulation n° 1272/2008 Annex VI table 3.2 and as Eye irritant category 2 according to EU CLP Regulation n° 1272/2008 Annex VI table 3.1.


Justification for selection of skin irritation / corrosion endpoint:
GLP study, OECD 404 compliant.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation: Based on the key study, PMP is slightly irritant for skin and is not classified for this endpoint.

Eye irritation: No conclusion can be drawn based on the two non reliable data. However, PMP is officially classified as Xi, R36 according to the EU CLP Regulation n° 1272/2008 Annex VI table 3.2 and as Eye irritant category 2 according to EU CLP Regulation n° 1272/2008 Annex VI table 3.1.