Registration Dossier

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:
2006-08-31 to 2006-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP study performed according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU method B.4 (Acute Toxicity: Dermal Irritation/Corrosion) with one deviation: the test substance was put on a surgical patch of approximately 4 cm X 4 cm (instead of 6 cm2) to ensure good contact and uniform distribution of test substance on the skin. This deviation, however, did not affect the validity of this study.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Deviation from the guideline was that the test substance was put on a surgical patch of approximately 4 cm X 4 cm (instead of 6 cm2) to ensure good contact and uniform distribution of test substance on the skin.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Deviation from the guideline was that the test substance was put on a surgical patch of approximately 4 cm X 4 cm (instead of 6 cm2) to ensure good contact and uniform distribution of test substance on the skin
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
: Certificate issued by the Swiss GLP Monitoring Authorities

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): T000268; (+-)-trans-3-methyl-1-[(4-methylphenyl)sulfonyl]-4-phenyl-4-piperidinecarbonitrile
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: solid
- Analytical purity: 100%
- Impurities (identity and concentrations): not applicable
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: BE A351
- Expiration date of the lot/batch: 2007-05-31
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: at room temperature (range of 20 +/- 5 deg C), light protected
- Other: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands BV (Kreuzeweg 53, NL-5961 NM Horst/The Netherlands; Postbus 6174, NL-5960 AD Horst/The Netherlands)
- Age at study initiation: 13-14 weeks (male); 14-15 weeks (females)
- Weight at study initiation: 2549 g (male); 2929 g (female, mean bw)
- Housing: individually in stainless steel cages with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: The acclimation period ranged from 5-6 days. Animals were kept under laboratory conditions after a health examination and only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2006-09-11 (one female), 2006-09-12 (one female and one male) To: 2006-09-15

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas were used as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (per animal)
- Concentration (if solution): not applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
4 hours
Observation period:
throughout 72 hours after treatment
Number of animals:
one male and two females
Details on study design:
TEST SITE
- Area of exposure: The left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10cm x 10 cm). The test substance was placed on a surgical gauze patch (4 cm X 4 cm) and applied to the intact skin of the clipped area.
- % coverage: no data
- Type of wrap if used: The surgical gauze patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 hours


SCORING SYSTEM:
- Skin reactions were assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The test substance did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythemal eschar and edema for each of the three animals was therefore 0. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
During the study, no clinical signs of systemic toxicity were observed in the animals and no mortality occurred. No staining of the treated skin was observed. The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

not applicable

Applicant's summary and conclusion

Conclusions:
The test substance was not a skin irritant to rabbit skin under the described conditions.
Executive summary:

not applicable