1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Endpoint summary

Description of key information

The substance is irritating to skin but not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

other: small white Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.3-2.4 kg
- Housing: individual in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 10.5 To: 24.5.1988

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 cm³ test substance

Duration of treatment / exposure:

4 h

Observation period:

1 h, 24 h, 48 h, 72 h, 6 days, 8 days, 10 days, 14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: mull patch (2.5 x 2.5 cm2) covered with a polyethylene film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 h exposure the substance residues are carefully washed off with warm water

OBSERVATION TIME POINTS
1, 24, 48, 72 h and 6, 8, 10 and days

SCORING SYSTEM:
- Method of calculation: according to OECD Guideline

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 14 days

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The substance showed an irritant effect on the skin of male rabbits.

Executive summary:

To test the acute skin irritant effect, the test substance was applied to the shaven dorsal skin of rabbits. The product was administered undiluted, and the time of exposure in the patch test was 4 hours. The test item showed an irritant effect on the skin of male rabbits, effects were fully reversible within 14 days.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

other: small white Russian

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 cm³

Duration of treatment / exposure:

72 h

Observation period (in vivo):

1 h, 24 h, 48 h, 72 h and 6 days

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 72 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Interpretation of results:

GHS criteria not met

Conclusions:

The test substsance caused slight, reversible irritation (iris score = 0, cornea, chemosis and redness scores <1), which does not require classification.

Executive summary:

The substance was tested undiluted in an acute eye irritation with rabbits test according to OECD Guideline 405. The test substsance caused slight, reversible irritation (iris score = 0, cornea, chemosis and redness scores <1), which does not require classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is one reliable study on the skin irritancy potential. Skin irritation was tested in a guideline study according to OECD guideline 404 in 3 small white Russian, Chbb-SPF rabbits. With reference the reported scores and the full reversibility of effects within 14 days the test item has to be classified as irritant to the skin (Cat. 2).

There is one reliable study available on the eye irritancy potential. The test item was tested for its eye irritant properties in 3 small white Russian rabbits. The study was performed according to OECD Guideline 405.With reference to the reported scores (iris score = 0, cornea, redness and discharge scores < 1) and reversibility of effects within 72 h the test substance does not have to be classified as irritant to the eyes.

Justification for classification or non-classification

Skin irritation:

With reference to the reported scores and the full reversibility of effects within 14 days the test item has to be classified as irritant to the skin according ( H 315) to the criteria laid down in Regulation (EC) No 1272/2008.

Eye irritation:

With reference to the reported scores and reversibility of effects within 72 h the test substance does not have to be classified as irritant to the eyes according to the criteria laid down in Regulation (EC) No 1272/2008.