Registration Dossier

Administrative data

Description of key information

In a non-GLP study conducted following methodology equivalent to OECD TG 404, a 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days.
In a non-GLP study conducted following methodology equivalent to OECD TG 405, instillation of 0.1 ml of sample into rabbit eyes resulted in minor (transient) corneal injury (opacity) in one of 6 animals. Iritis was apparent in 5 eyes and moderate conjunctival irritation, with a substantial amount of discharge, developed in all 6 rabbits. By 48 hours, 5 eyes had a normal appearance. One eye had only slight conjunctival redness. All 6 eyes were healed after 72 hours

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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 404 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 3.0 kg
- Fasting period before study: no
- Housing: assumed to be individually housed
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: intact, clipped skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4-hours
Observation period:
one hour, one day, 2 days, 3 days and 7 days
Number of animals:
3 males + 3 females
Details on study design:
The dose was applied to the clipped, intact skin of 6 rabbits under a gauze patch and is loosely covered with impervious sheeting and the animals restrained for the 4-hour contact period. Excess sample was removed after contact period.
Irritation parameter:
erythema score
Remarks:
of 6 animals
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
of 6 animals
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
A 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days.
Other effects:
none

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for skin irritation
Executive summary:

In this study, three male and three female New Zealand White rabbits were dermally dosed with 0.5 ml of undiluted n-propyl propionate. The dose was applied to the clipped, intact skin of 6 rabbits under a gauze patch and was loosely covered with impervious sheeting and the animals restrained for the 4-hour contact period. Excess sample was removed after contact period. Skin reaction was scored, by the method of Draize, at one hour, one day, 2 days, 3 days and 7 days.

A 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days. Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for skin irritation.

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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 405 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 3.0 kg
- Fasting period before study: no
- Housing: assumed to be individually housed
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
approximately 1 second
Observation period (in vivo):
one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing
Number of animals or in vitro replicates:
3 males + 3 females
Details on study design:
The dose was instilled into the lower conjunctival sac of one eye per animal. The eyelids were held together for one second. The eyes were scored by the Draize system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 ours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Instillation of 0.1 ml of sample into rabbit eyes resulted in minor (transient) corneal injury (opacity) in one of 6 animals. Iritis was apparent in 5 eyes and moderate conjunctival irritation, with a substantial amount of discharge, developed in all 6 rabbits. By 48 hours, 5 eyes had a normal appearance. One eye had only slight conjunctival redness. All 6 eyes were healed after 72 hours.
Other effects:
none

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for eye irritation.
Executive summary:

In this three Male and three female New Zealand White rabbits were topically dosed with 0.1 ml of undiluted n-propyl propionate. The dose was instilled into the lower conjunctival sac of one eye per animal. The eyelids were held together for one second. The eyes were scored by the Draize system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.

Instillation of 0.1 ml of sample into rabbit eyes resulted in minor (transient) corneal injury (opacity) in one of 6 animals. Iritis was apparent in 5 eyes and moderate conjunctival irritation, with a substantial amount of discharge, developed in all 6 rabbits. By 48 hours, 5 eyes had a normal appearance. One eye had only slight conjunctival redness. All 6 eyes were healed after 72 hours.Under the conditions of the study, as the dermal LD50 of n-propyl propionate is in excess of 14000 mg/kg, hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for eye irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin Irritation:

In a non-GLP study conducted following methodology equivalent to OECD TG 404, a 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days.

Eye Irritation

In a non-GLP study conducted following methodology equivalent to OECD TG 405, instillation of 0.1 ml of sample into rabbit eyes resulted in minor (transient) corneal injury (opacity) in one of 6 animals. Iritis was apparent in 5 eyes and moderate conjunctival irritation, with a substantial amount of discharge, developed in all 6 rabbits. By 48 hours, 5 eyes had a normal appearance. One eye had only slight conjunctival redness. All 6 eyes were healed after 72 hours


Justification for selection of skin irritation / corrosion endpoint:
The study methodology followed was equivalent or similar to OECD TG 404

Justification for selection of eye irritation endpoint:
The study methodology followed was equivalent or similar to OECD TG 405

Justification for classification or non-classification

In teh absence of any skin or eye irritation and based on the guidance to Regulation (EC) No. 1272/2008 on Classification, Labeling, and Packaging of substances and mixture, propyl propionate will not be classified as a skin or an eye irritant.