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:
2006-07-05 to 2006-07-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-documented,GLP-compliant study performed according to OECD Guideline No. 404 and EU Method B4. No major deviations were recorded.

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:
The test substance was put on with a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm x 6 cm).
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The test substance was put on with a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm x 6 cm).
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate from 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): T1310 (chemical name: 4-piperidinecarboxylic acid hydrochloride; CAS number: 005984-56-5)
- Substance type: no data
- Physical state: solid
- Analytical purity: 100%
- Purity test date: no data
- Lot/batch No.: 00465047 RT001310G4A851
- Expiration date of the lot/batch: 2011-05-06
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: At room temperature (range of 20 ± 5 °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, Kreuzelweg 53, NL-5961 NM Horst I The Netherlands Postbus 6174, NL-5960 AD Horst I The Netherlands
- Age at treatment: 15-16 weeks (male), 10-11 weeks (females)
- Weight at study initiation: no data
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 24/06) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Fullinsdorf, ad libitum
- Acclimation period: 2006-07-05 to 2006-07-09 (one female); 2006-07-05 to 2006-07-10 (one male and one female); under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark.


IN-LIFE DATES: From: 2006-07-10 To: 2006-07-14

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal
- Concentration (if solution): 0.5 mL of purified water used to moisten test material before application


VEHICLE
- Amount(s) applied (volume or weight with unit): approximately 0.5 mL
- Concentration (if solution): not applicable
- Lot/batch no. (if required): no data
- Purity: no data
Duration of treatment / exposure:
4 hours
Observation period:
The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
Number of animals:
3 animals (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: an area of approximately 100 cm2 (10 cm x 10 cm) of the left flank
- % coverage: no data
- Type of wrap if used: T1310 was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The 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): flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hours


SCORING SYSTEM:
- The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004173/EC, April 29, 2004.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. An animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or oedema).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Not Irritating
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Not Irritating
Irritant / corrosive response data:
The test item 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 erythema/eschar and oedema 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:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. No staining produced by the test item of the treated skin was observed. The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The application of T1310 to the skin resulted in no signs of irritation. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), T1310 is considered to be "not irritating" to rabbit skin.