Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Endpoint summary

Description of key information

No data on the test item is available. With the read-across substances the following results were obtained:

Skin irritation: CAS 68583-51-7 not irritating

Eye irritation: CAS 68583-51-7 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:

April 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: F .D .A . Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p.47.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Remarks:

68583-51-7

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
no details available

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5 mL test substance

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

Number of animals:

six

Details on study design:

TEST SITE
- Area of exposure: back
- Size: one inch
- Type of wrap: rubberised cloth

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATION TIME POINTS
24 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize system

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

At no time during the experiment did the material under test cause any reaction on the rabbit back.

Interpretation of results:

GHS criteria not met

Conclusions:

The skin irritation was investigated on rabbits. At no time point during the experiment did the test item cause any reaction.

Executive summary:

In the test on skin irritation of the test item six New Zealand White rabbits were restrained in suitable stocks. Their backs were shaved with electric clippers and one side of each back abraded with a suitable abrading tool. Under a one squar inch patch, 0.5 mL of the test substance was introduced. The patches were kept in place with adhesive tape and the entire trunk of the animal wrapped with rubberised cloth for the entire 24 hour period of exposure. After 24 h the patches were removed and the resultant reactions evaluated according to the Draize system. Readings were made at 24 and 72 h and both intact and abraded areas taken into account. At no time during the experiment did the material under test cause any reaction on the rabbit back. It is concluded that, under the conditions of the experiment, the test item is innocuous.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to Chapter 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

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:

1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: F.D.A. Handbook Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics 1959 p.49

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no details available
- Age at study initiation: adults

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

1, 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: In three rabbits the treated eye remained unwashed, in three rabblts the treated eyes were washed.
- Time after start of exposure: 4 seconds after instillation with 20 mL lukewarm water

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: washed and unwashed

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: washed and unwashed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: washed

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: unwashed

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: unwashed

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: unwashed

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: washed and unwashed

Irritant / corrosive response data:

The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris. Please refer to Tabel 1 for details.

Table 1: Details on results

			Cornea		Iris	Conjunctivae
	Animal	Day	Opacity	Area		Redness	Chemosis	Discharge
Unwashed	1	1	0	0	0	1	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	2	1	0	0	0	2	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	3	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
Washed	4	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	5	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0
	6	1	0	0	0	0	0	0
		2	0	0	0	0	0	0
		3	0	0	0	0	0	0
		4	0	0	0	0	0	0
		7	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The eye irritation was investigated on six rabbits. Only slight erythema of the conjunctivae were detected and failed to persist beyond 24 hours after administration.

Executive summary:

For the test on eye irritation six adult New Zealand white rabbits were used. A 0.1 ml sample of the test material was instilled into one eye of each rabbit, the contralateral eye remaining untreated as a control. In three rabbits the treated eye remained unwashed, in three rabblts the treated eyes were washed with 20 ml lukewarm water 4 seconds after instillation. Readings were made at 1, 2, 3, 4 and 7 days to assess the irritant effects on various parts of the eyes. These assessments were made according to the Draize scale. The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to Chapter 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: washed and unwashed

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: washed and unwashed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

3

Remarks on result:

other: washed

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: unwashed

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: unwashed

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: unwashed

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: washed and unwashed

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No data on the test item is available. With the read-across substances the following results were obtained:

In the test on skin irritation of the read across substance CAS 68583-51-7 six New Zealand White rabbits were restrained in suitable stocks. Their backs were shaved with electric clippers and one side of each back abraded with a suitable abrading tool. Under a one inch patch, 0.5 mL of the test substance was introduced. The patches were kept in place with adhesive tape and the entire trunk of the animal wrapped with rubberised cloth for the entire 24 hour period of exposure. After 24 h the patches were removed and the resultant reactions evaluated according to the Draize system. Readings were made at 24 and 72 hr. and both intact and abraded areas taken into account. At no time during the experiment did the material under test cause any reaction on the rabbit back. It is concluded that, under the conditions of the experiment, the test item is innocuous.

For the test on eye irritation six adult New Zealand white rabbits were used. A 0.1 mL sample of the read across substance CAS 68583-51-7 was instilled into one eye of each rabbit, the contralateral eye remaining untreated as a control. In three rabbits the treated eye remained unwashed, in three rabbits the treated eyes were washed with 20 mL lukewarm water 4 seconds after instillation. Readings were made at 1, 2, 3, 4 and 7 days to assess the irritant effects on various parts of the eyes. These assessments were made according to the Draize scale. The sample was found to be virtually nonirritating to the eyes of rabbits under the conditions of this experiment. Where reactions were produced, they were confined to slight erythema of the conjunctivae and failed to persist beyond 24 hours after administration of the test material. At no time throughout the experimental period were any effects observed which involved the cornea and iris.

Based on the results of the read across susbtance the test item is not irritant to eye or skin.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on eye and skin irritation, the test item is classified and labelled as not irritant to eye and skin according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.