Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Endpoint summary

Description of key information

Skin irritation (OECD TG 404): Not irritating.
Eye irritation (OECD TG 405): Not irritating. 
Respiratory irritation (based on absence human data and of irritation for skin and eye): no adverse effects observed. .

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:

June 14, 1999 - June 17, 1999

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:

(1992)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 3034g; females: 2447 and 2861g
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance (batch no. 64/99)
- Water: Free access to community tap water from Itingen
- Acclimation period: under laboratory conditions after health examination for 6 days.

ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

1 male
2 females

Details on study design:

TEST SITE
Approximately three days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm^2 (10 cm x 10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.

TREATMENT
On the day of treatment, the test substance was applied approximately 6 cm^2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the guidelines. If evident, corrosive or staining properties of the test substance were described and recorded.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

other: mean 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2 and #3 (females)

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

other: mean 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2 and #3 (females)

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.

Other effects:

No staining by the test substance of the treated skin was observed.

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

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) No. 1272/2008 and its updates

Conclusions:

In a skin irritation study with 3 rabbits, performed according to OECD 404 guideline and GLP principles, very slight erythema and very slight oedema was observed in one male. All signs of irritation were fully reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed. The substance also does not need to be classified according to GHS.

Executive summary:

The substance was tested for 4 hours in a skin irritation test in 3 rabbits according to OECD TG 404 test guideline and GLP principles.

In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Based on the results, the substance does not need to be classified for skin irritation/skin corrosion according to Regulation (EC) No. 1272/2008 and GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

June 21, 1999 - June 24, 1999

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:

(1987)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 2613g; females: 2726 and 2581g
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance (batch no. 64/99)
- Water: Free access to community tap water from Itingen
- Acclimation period: under laboratory conditions after health examination for 6 days.

ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye remained untreated and served as the reference control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

1 male
2 females

Details on study design:

TREATMENT:
The test substance was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test substance.

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the guidelines at approximately 1, 24, 48 and 72 hours after administration. When present, corrosion of and/or staining of sclera and cornea by the test substance were recorded and reported.

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp.

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs.

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs.

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs.

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs.

Score:

0

Max. score:

4

Irritant / corrosive response data:

In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.

Other effects:

The body weights of all rabbits were considered to be within the normal range of variability.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) No. 1272/2008 and its updates.

Conclusions:

In an eye irritation study with 3 rabbits, performed according to OECD 405 guideline and GLP principles, slight irritation was observed. All signs of irritation were reversible within 24 hours. The substance does also not need to be classified according to GHS

Executive summary:

The substance was tested for 4 hours in an eye irritation test in 3 rabbits according to OECD TG 405 test guideline and GLP principles.

In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Based on the results, the substance does not need to be classified for eye irritation according to Regulation (EC) No. 1272/2008 and its updates.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

The substance was tested for 4 hours in a skin irritation test in 3 rabbits according to OECD TG 404 test guideline and GLP principles.

In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Eye irritation:

The substance was tested for 4 hours in an eye irritation test in 3 rabbits according to OECD TG 405 test guideline and GLP principles.

In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.

Respiratory irritation: For assessing respiratory irritation human data are key for assessing this endpoint. Animal data may be used to indicate effects (ECHA guidance, R7.2.4.1, 2014). The substance is not an irritant and therefore respiratory irritation is not anticipated either.

Justification for classification or non-classification

Based on the results, the substance does not need to be classified for skin eye and respiratory irritation/corrosion according to Regulation (EC) No. 1272/2008 and its amendments.