Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Jun - 13 Jul 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted Apr 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): PM-5927
- Physical state: off-white powder
- Lot/batch No.: 07-02
- Expiration date of the lot/batch: 05 Feb 2008
- Storage condition of test material: at room temperature in the dark
- Other: pH (1% in water, indicative range) 5.2 - 6.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, the Netherlands
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 1594 - 1963 g (range)
- Housing: animals were housed individually in cages with perforated floors (56 x 44 x 37.5 cm, Scanbur, Denmark)
- Diet: pelleted diet for rabbits, K-H (SSNIFF Spezialdiäten GmbH, Soest, Germany), approximately 100 g/day. Hay (TechniLab-BMI BV, Someren, the Netherlands) was provided at least 3 times/week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 24.1 (actual range)
- Humidity (%):44 - 80 (actual range)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with 0.5 mL water
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
- Type of wrap if used: the test area was covered with a Metalline gauze patch, which was held in place with Micropore tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed from the treated area using tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No local reactions were observed after topical application of the test substance. The erythema and oedema scores were 0 for 3/3 animals at all reading time points.
Other effects:
There was no mortality. No clinical signs were observed and the body weight increase was within the normal range defined for this species.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified