4-pentylcyclohexanone

Endpoint summary

Description of key information

Skin irritation:

A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin of rabbits for a 4 hour period under occlusive conditions. Under the conditions of the study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.1 -1).

Eye irritation:

A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits. In the primary eye irritation test no irritation of the cornea was observed. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally. The test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.2 -1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 12 until February 26, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.87 (2.77 - 2,98) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 (1m and 2f )

Details on study design:

TEST SITE
- Area of exposure: 24 hours before the start of the study the backs and flanks of the animals were cautiously shaved with an electronic clipper so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept in place by leather sleeve.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.

OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behavior, and general condition 1 hour after removal of the patches, and then daily for a period of further 14 days.
All rabbits were weighed before start of the study and on days 5, 8, 11 and 15.

SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to the DRAIZE and OECD recommendations.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Other effects:

- Other adverse local effects:
Single application of 0.5 mL test item to the intact dorsal skin of rabbits led to irritation of the skin.
Beginning from day 2, and then up to day 7 of the study, erythema and edema were observed. They were followed by other irritation symptoms i.e. formation of large scales and smaller scales from day 5 up to day 12.

- Other adverse systemic effects:
No signs of systemic toxicity were detected. The body weight development was normal. All rabbits survived the 15 day observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.

Executive summary:

A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin (for a 4 hour period under occlusive conditions) of rabbits. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for a further 14 days. The skin irritation test revealed slight irritation. Beginning at the second reading, up to day 7 of the study, erythema and edema occurred (max. score 1), which from day 5 up to 12 were followed by other irritation symptoms, i.e. formation of large scales and smaller scales. Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 12 until February 26, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.73 (2.66 - 2.80) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12

To ensure that only rabbits without ocular abnormalities were included in the study, 24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution using an ophthalmoscope after Eisenhut.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 (1m and 2f)

Details on study design:

The rabbits were investigated for eye irritation and for changes in behavior and general condition 1 hour after treatment and then daily for a period of further 7 days. All rabbits were weighed before the start of the study and on days 5 and 8.

- Washing: no

SCORING SYSTEM: Local changes of the eye were evaluated according to the recommendations of the OECD

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 3 days

Irritation parameter:

other: discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 2 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 3 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 4 days

Irritation parameter:

other: discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 2 days

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 2 days

Irritation parameter:

other: discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 1 day

Irritation parameter:

chemosis score

Basis:

animal: #1-3

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Other effects:

- Ophthalmoscopic findings:
No irritation of the cornea was observed. At one reading (animal No. 90013, day 3) congestion of the iris was observed. Examination of the conjunctivae revealed redness and discharge beginning at the first reading up to day 4, maximally.

- Other observations:
No signs of systemic toxicity were seen. The body weight development was normal. All animals survived the 8 day observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of this study the test material is not to be classified as an irritant for eyes.

Executive summary:

A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits (left eye). The right eye served as untreated control. The first examination of the eyes was performed 1 hour after instillation. Then examinations were performed daily for 7 days. In the primary eye irritation test no irritation of the cornea was observed. Congestion of the iris (value 1) was seen in one rabbit on day 3. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally.The test item is not requiring classification for skin irritation according to (EC) No 1272/2008.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin (for a 4 hour period under occlusive conditions) of rabbits. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for a further 14 days.The skin irritation test revealed slight irritation. Beginning at the second reading, up to day 7 of the study, erythema and edema occurred (max. score 1), which from day 5 up to 12 were followed by other irritation symptoms, i.e. formation of large scales and smaller scales.Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.1 -1).

Eye irritation:

A study was performed according to OECD 405 under GLP conditions. To test for primary eye irritation the test item was instilled into the conjunctival sac of rabbits (left eye). The right eye served as untreated control. The first examination of the eyes was performed 1 hour after instillation. Then examinations were performed daily for 7 days. In the primary eye irritation test no irritation of the cornea was observed. Congestion of the iris (value 1) was seen in one rabbit on day 3. The conjunctivae showed redness and discharge at the first reading up to day 4, maximally. The test item is not requiring classification for skin irritation according to (EC) No 1272/2008 (reference 7.3.2 -1).

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin irritation and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is neither considered to be classified for skin irritation nor for eye irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) No 2019/521.