Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404),

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- housing temperature occasionally below the minimum level and relative humidity temporily above the optimum maximal level. Based on laboratory historical data these deviations were considered not to have affected the study integrity
GLP compliance:
yes

Test material

Constituent 1
Details on test material:

- Physical apprearance: Light yellow viscous liquid
- Batch: 99/484
- Storage: RT in the dark
- Stability undert storage conditions: not indicated
- Specific gravity: 1.23
- Purity: 99% (HPLC)
- Expiry date: 10th June 2005 (allocated by NOTOX, 1 year after receipt of the test substance)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Sex: male
- Weight at study initiation: => 1 kg
- Housing: individually
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g per day. In addition, hay (BMI, Helmond, the Netherlands) was provided at least three times a week.
- Water: Free access to tap-water
- Acclimation period: =>5 days. A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.7 - 22.2
- Humidity (%): 37-74%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated flank of the same animal
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
1; 24; 48 and 72 hours
Number of animals:
3
Details on study design:
The study was designed as such that, first a single rabbit (sentinel) was treated. The two other animals were treated in a similar manner two weeks later, after considering the degree of skin irritation observed in the first animal.

TEST SITE
- Shaving: performed approx 24 hour prior to treatment (10 x 15 cm2). If required, shaving was was again performed at least 3 hours before treatment
- Area of exposure: 2 X 3 cm
- Application volume: 0.5 ml
- Type of wrap if used: The test substance was applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape which was wrapped a round the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

OBSERVATION
- Mortality: twice daily
- Toxicity: at least once daily
- Body weight measurements: day of treatment (prior to appliation) and the termination
- Histopathology: no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 -72
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 -72
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritation was caused at any time
Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred
- No staining of the treated skin by the test substan ce was obse rved and no test substance remnants were seen

Applicant's summary and conclusion

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