2,6-dimethyloct-7-en-2-yl acetate

Endpoint summary

Description of key information

Skin corrosion: Not corrosive in absence of skin and eye irritation

Skin irritation: not irritating

Eye irritation: not irritating

Respiratory irritation (in absence of human data and skin and eye irritation): not irritating

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:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Test conducted prior to the GLP guidelines.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: FDA of the United States

Version / remarks:

FDA of the United States (Fed. Reg .28 (119), 5582 1963)

Qualifier:

according to guideline

Guideline:

other: Draize and Kelley

Version / remarks:

Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)

GLP compliance:

no

Remarks:

Test conducted priro to the GLP guidelines

Specific details on test material used for the study:

Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Twelve healthy adult albino rabbits are used

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of undiluted the test substance is brought on the skin

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

Six rabbits are treated on the intact skin and Six others on the abraded skin

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin, also animal 8959 and 8960

Remarks:

24 and 72 hours were scored

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin, also animal 8961

Remarks:

24 and 72 hours were scored

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin, 1 animal

Remarks:

24 and 72 hours were scored

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin, 5 animals; 5857, 8959, 8960, and 8961

Remarks:

24 and 72 hours were scored

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: intact skin, 1 animal

Remarks:

24 and 72 hours were scored

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: 1 animal

Remarks:

24 and 72 hours were scored

After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema.

After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness.

There were no disctinct differences between reactions of the intact and those of the abraded skin. From these results it appear that DHMA is a moderate primary skin irritant.

Interpretation of results:

other: Not a skin irritant.

Remarks:

According to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

The substance is not a skin irritant in the OECD TG 404 using EU CLP criteria, but it is classified Category 3 (mild irritant) based on GHS criteria.

Executive summary:

The substance was examined for primary skin irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods somewhat similar to OECD TG 404. Six rabbits, previously clipped on the backs, are treated on the intact skin and Six others on the abraded skin with 0.5 ml of the undiluted test material. After an exposure of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours application). After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema. After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness. There were no disctinct differences between reactions of the intact and those of the abraded skin.

From the results of the present study it can be concluded that the substance irritation seen is insufficient for being a skin irritant.

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:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Test conducted prior to the GLP guidelines

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: FDA of the United States

Version / remarks:

FDA of the United States (Fed. Reg .28 (119), 5582 1963)

Qualifier:

according to guideline

Guideline:

other: Draize and Kelley

Version / remarks:

Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)

GLP compliance:

no

Remarks:

Test conducted prior to the GLP guidelines

Specific details on test material used for the study:

Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Six New Zealand White albino rabbits are used for each test substance. The animals are cages individually and receive no hay or other extraneous materials that might enter the eyes.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

10 ml of undiluted test material

Duration of treatment / exposure:

instillation

Observation period (in vivo):

The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.

Duration of post- treatment incubation (in vitro):

none

Number of animals or in vitro replicates:

Six New Zealand White albino rabbits

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

Mean of 2 animals and only 24 and 48 hours scored

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

mean of 2 animals

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

Mean of 2 animals

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other:

Remarks:

Mean of 2 animals and only 24 and 48 hours scored

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

2

Remarks on result:

other:

Remarks:

Mean of 2 animals

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

2

Remarks on result:

other:

Remarks:

Mean of 2 animals

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other:

Remarks:

Mean of 2 animals and only 24 and 48 hours scored

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

other:

Remarks:

Mean of 2 animals

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other:

Remarks:

Mean of 2 animals and only 24 and 48 hr scored

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

other:

Remarks:

Mean of 2 animals

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

other:

Remarks:

Mean of 2 animals

Irritant / corrosive response data:

DHMA caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up.

An animal is considered as giving a positive reaction if there is, at any of the reading, discernible opacity of the cornea or inflammation of the iris (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection) or if such susbtance produces in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with the partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA scoring scale is used.

Interpretation of results:

other: not an eye irritant

Remarks:

according to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.

Executive summary:

The substance was examined for eye irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods, somewhat similar to OECD TG 405. The eyes of animals are examined before testing and only those animals without observable eye defects are used. One tenth of milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent the loss of material. The eyes are not washed following instillation and the animals are released immediately. The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.

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 adverse effect observed (not irritating)

Additional information

Skin irritation

The substance was examined for primary skin irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods somewhat similar to OECD TG 404. Six rabbits, previously clipped on the backs, are treated on the intact skin and Six others on the abraded skin with 0.5 ml of the undiluted test material. After an exposure of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours application). After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema. After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness. There were no disctinct differences between reactions of the intact and those of the abraded skin.

From the results of the present study it can be concluded that the substance irritation seen is insufficient for being a skin irritant.

Eye irritation

The substance was examined for eye irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods, somewhat similar to OECD TG 405. The eyes of animals are examined before testing and only those animals without observable eye defects are used. One tenth of milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent the loss of material. The eyes are not washed following instillation and the animals are released immediately. The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.

Respiratory irritation

There are no occupational or consumer data indicating respiratory tract irritation. There are also no relevant experimental guidelines or results available that indicate respiratory irritation, therefore respiratory irritation is not anticipated. The substance is also not a skin irritant and not an eye irritant and therefore there is no indication for respiratory irritation.

Justification for classification or non-classification

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