4-Piperidinone, 2,6-diethyl-2,3,6-trimethyl-1-(1-phenylethoxy)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD-and EEC-Guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

Identificaflon: TKA 40270
Product name: CGPS 345

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 12 weeks (male); 12 weeks (females)
Acclimatization: Under laboratory conditions after health examination (animals without any visual signs of iliness were used)
Allocation: Male No. 56; Female Nos. 57 and 58

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0. 5 mL of TKA 40270

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 h and 7 days

Number of animals:

3

Details on study design:

The primary skin irritation potential of TKA 40270 (CGPS 345) was investigated according to OECD test guideline no. 404, The test item was applied
by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of
treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as weil as 7 days after removal of the dressing.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean at 24, 48, 72 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean at 24, 48 and 72 hours

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean at 24, 48 and 72 hours

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean at 24, 48 and 72 hours

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean at 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean at 24, 48 and 72 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

VIABILITY/MORTALITY/CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

IRRITATION:
Well-defined erythema was observed in all animals at the 1-hour reading. Very slight to well defined erythema was noted in all animals 24 hours after treatment and very slight erythema was visible in all animals at the 48-hour examination and persisted in two animais up to 72 hours after treatment.
Very slight swelling (oedema) was observed in all animais at the 1-hour reading and persisted in two animals up to 24 hours after treatment and in
one animal up to the 72-hour examination.
Scaling was present in two animals at the 72-hour reading.
No abnormal findings were observed on the treated skin of any animal 7 days after treatment, the end of the observation time.
No staining produced by the fest kern of the treated skin was observed.

CORROSION:
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

BODY WEIGHTS:
The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal tor erythema/eschar grades and tor oedema grades, separately. The mean erythema/eschar score of the three animals was 1.00, 0.67 and 1.33, respectively and the mean oedema score was 0.33, 0.00 and 1.00, respectively.

The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema, oedema and scaling. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. 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 other clinical signs of substance related effects were observed.

Thus, the test item did not induce significant or irreversible damage to the skin. TKA 40270 (CGPS 345) is considered to be “not irritating“ to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item did not induce significant or irreversible damage to the skin and is therefore considered to be “not irritating“ to rabbit skin.