Propylene dinonanoate

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating

Skin, human (volunteer study, GCP): not irritating

Eye irritation(similar to OECD 405): not irritating

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

 

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:

01 to 11 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Purity of test substance not reported. No GLP statement. Limited reporting details.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

no rationale for in vivo testing, no initial testing with one animal

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

yes

Remarks:

Purity of test substance not reported. No GLP statement. Limited reporting details.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Legard
- Weight at study initiation: 1.97 kg

IN-LIFE DATES: 01 Mar 1991 to 08 Mar 1991

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: not stated

REMOVAL OF TEST SUBSTANCE
- Washing: no washing was performed

OBSERVATION TIME POINTS
1, 24, 48, and 72 h

SCORING SYSTEM:
No details reported.

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

No purity of test substance reported.

Qualifier:

according to guideline

Guideline:

other: Journal Officiel de la Republique Francoise 1971/1973

Deviations:

not specified

Principles of method if other than guideline:

Study was conducted prior to adoption of any OECD guideline.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3.5 kg
- Housing: individual in 600x540x315 mm cages or in restraining devices
- Diet: 200g feed per day, commercial rabbit feed.
- Water: ad libitum
Animals were vaccinated against Myxomatosis and Pasteurellosis. Only healthy animals without signs of skin lesions were included.

ENVIRONMENTAL CONDITIONS
Air conditioned.

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

back of rabbit, 14 cm x 14 cm clipped. Superficial incisions were made to the right flank.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of undiluted test substance

Duration of treatment / exposure:

23 h

Observation period:

Readings at 24 and 72 hours after start of exposure.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Test substance was placed on two squares of sterile absorbent gauze measuring 2 cm x 2 cm; each square was composed of four layers of gauze. The gauze was placed on the left (intact skin) and right flank (incised skin) and held in contact with skin with an occlusive patch, which was adhesive and non-allergic. Additional an adhesive tape was wrapped around the animals.

SCORING SYSTEM:
Erythema: 0 (no), 1 (slight), 2 (well defined), 3 (moderate to severe), 4 (severe with slight eschar formation - injury in depth)
Edema: 0 (no), 1 (very slight), 2 (slight - definite raising), 3 (moderate), 4 (severe)

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

individual mean over

Time point:

other: 24h/72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other:

Remarks:

left flank

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

individual mean over

Time point:

other: 24h/72h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other:

Remarks:

left flank

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

No purity of test substance reported.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

not applicable

Qualifier:

according to guideline

Guideline:

other: Journal Officiel de la Republique Francaise 1971/1973

Deviations:

not specified

Principles of method if other than guideline:

Study was conducted prior to adoption of any OECD guidelines.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: about 2.5 kg at study start
Animals were vaccinated against myxomatosis and selected only if normal eye condition; any rabbits with ocular lesions were excluded.
- Housing: Individual cages (600x540x315 mm) or restraining devices
- Diet: 200 g commercial rabbit feed per day in the form of granules
- Water: ad libitum
- Climate: air conditioned

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, each animals untreated right eye served as control

Amount / concentration applied:

0.1 mL of undiluted test substance as supplied by sponsor was instilled to the left eye.

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

Readings were after 1, 24, 48, 72 hours, and 4 and 7 days after administration

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
No rinsing of eyes was done.

SCORING SYSTEM:
Chemosis: Scores 0-4
Conjunctival enanthema: Scores 0-3
Iris: Scores 0-2
Corneal opacity: Scores 0-4

TOOL USED TO ASSESS SCORE: ophtalmoscope

Irritation parameter:

chemosis score

Basis:

animal: #1, #3, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal: #4, #5

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, 5#, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

animal #5

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3, #5, #6

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48h

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #4

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Other effects:

No mortality occurred during this study.

		Animal #
	Reading time [hour]	#1	#2	#3	#4	#5	#6
Chemosis	24	0	1	0	0	0	1
Chemosis	48	1	1	1	0	0	0
Chemosis	72	0	0	0	0	0	0
	Individual mean	0.33	0.67	0.33	0.0	0.0	0.33
Redness conjunctivae	24	1	0	1	0	1	1
Redness conjunctivae	48	0	0	0	0	0	0
Redness conjunctivae	72	0	0	0	0	0	0
	Individual mean	0.33	0.0	0.33	0.0	0.33	0.33
Iris	24	0	0	0	0	1	0
Iris	48	0	0	0	0	0	0
Iris	72	0	0	0	0	0	0
	Individual mean	0.0	0.0	0.0	0.0	0.33	0.0
Cornea opacity	24	0	0	0	0	0	0
Cornea opacity	48	0	0	0	0	0	0
Cornea opacity	72	0	0	0	0	0	0
	Individual mean	0.0	0.0	0.0	0.0	0.0	0.0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Skin irritation

A skin irritation study was conducted with Propylene dinonanoate (CAS 41395-83-9) according to OECD guideline 404 (key study, 1991). 0.5 mL of the undiluted test substance was applied to the skin of 3 male rabbits for 4 hours of exposure under occlusive conditions. The skin irritation effects were scored at 1, 24, 48 and 72 hours. No signs of skin irritation were observed. The individual mean oedema and erythema scores over 24/48/72 hours were 0.0 for each of the 3 rabbits. The results of the study indicate no skin irritation potential.

A skin irritation study was conducted with Propylene dinonanoate (CAS 41395-83-9) similar to OECD guideline 404 (supporting study, 1977). 0.5 mL of the undiluted test substance was applied to the clipped, intact skin of 6 rabbits for 23 hours of exposure under occlusive conditions. The skin irritation effects were scored at 24 and 72 hours after start of exposure. No signs of skin irritation were observed. The individual mean oedema and erythema scores over 24/72 hours after start of exposure were 0.0 for each of the 6 rabbits. The results of the study indicate no skin irritation potential.

A single patch test with 10 healthy adult female volunteers was conducted with Propylene dinonanoate (CAS 41395-83-9). 0.02 mL of the undiluted test substance were applied on the back, on a surface of about 50 mm², on a filter paper and were occlusively covered with a "Finn Chamber" (aluminium disc) and held in place with an adhesive tape. The test article was applied only once. After an exposure of 48 h, patches were removed and substantial amount of remaining test material was removed using a hydrophilic pad. Macroscopic examination of the skin was done about 30 minutes after patch removal. No skin reactions were observed in any of the 10 volunteers. The test substance was well tolerated.

 

Based on the results of the available studies Propylene dinonanoate (CAS 41395-83-9) is not irritating to skin.

Eye irritation

An eye irritation study was conducted with Propylene dinonanoate (CAS 41395-83-9) similar to OECD guideline 405 (key study, 1977). 0.1 mL of undiluted test substance was instilled into one eye of each of 6 New Zealand White rabbits. The animals were observed for 7 days. Scoring according to the Draize system was performed 1, 24, 48, 72 hours, and 4 and 7 days after instillation. Only mild signs of eye irritation were seen, which were all fully reversible within 72 hours. The individual mean conjunctivae scores over 24/48/72 hours were 0.33 in 4/6 and 0.0 in 2/6 rabbits. The individual mean chemosis scores over 24/48/72 hours were 0.67 in 1/6, 0.33 in 3/6 and 0.0 in 2/6 rabbits. The individual mean cornea opacity scores over 24/48/72 hours were 0.0 in 6/6 rabbits. The individual mean iris scores over 24/48/72 hours were 0.33 in 1/6 and 0.0 in 5/6 rabbits. Under the conditions of the study, the test substance showed no eye irritation potential leading to classification.

Overall conclusion for skin and eye irritation

No skin and only mild eye irritation potential was shown for Propylene dinonanoate (CAS 41395-83-9).

Justification for classification or non-classification

The available in vivo data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.