Registration Dossier

Administrative data

Description of key information

Skin, rabbit (according OECD 404): not irritating

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

Eye, rabbit (similar to OECD 405): not irritating

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:
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.
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

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.