Registration Dossier

Administrative data

Description of key information

In a non-GLP study conducted following methodology equivalent to OECD TG 404, the mean erythema and edema scores over New Zealand White 6 rabbits exposed to 0.5 ml of pentyl propionate was 0, i.e. no signs of erythema and edema were noted in any of the exposed animals. 
In a non-GLP study conducted following methodology equivalent to OECD TG 405, the mean corneal, iris, chemosis and conjunctival scores over 6 New Zealand White rabbits exposed to 0.1 ml of pentyl propionate was 0, i.e. no signs of eye irritation were noted in any of the exposed animals.

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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was according to OECD TG 404 and the report contains sufficient information to permit a meaningful evaluation of study results
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:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 2.0-3.0 kg
- Housing: group housed
- Diet (e.g. ad libitum): appropriate commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml undiluted UCAR n-pentyl propionate
Duration of treatment / exposure:
4 hours
Observation period:
one hour, 1 day, 2 days, 3 days and 7 days
Number of animals:
3 male + 3 female rabbits
Details on study design:
New Zealand White rabbits were dosed topically with 0.5 ml of UCAR n-pentyl propionate to the clipped intact skin of the trunk under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour contact period. Excess samples were removed after the contact period and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days and 7 days with perios extended upto 14 days depending on the skin recations noted.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No signs of erythema and edema were noted in any of the exposed animals
Other effects:
One female rabbit was found dead on day 7 with no apparent signs of irritation, concluded to be not treatment related

None

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

In this study, the skin irritation potential of undiluted UCAR n-pentyl propionate was evaluated on three male and three female New Zealand White rabbits over a 4 hour contact period. The animals were dosed topically with 0.5 ml of UCAR n-pentyl propionate to the clipped intact skin of the trunk under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour contact period. Excess samples were removed after the contact period and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days and 7 days with perios extended upto 14 days depending on the skin recations noted. No signs of erythema and edema were noted in any of the exposed animals. One female rabbit was found dead on day 7 with no apparent signs of irritation, concluded to be not treatment related. Under the conditions of the study, UCAR n-pentyl propionate would not be be classified as a skin irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.

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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent to OECD TG 405 and the report contains sufficient information to permit a meaningful evaluation of study results
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:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 2.0-3.0 kg
- Housing: group housed
- Diet (e.g. ad libitum): appropriate commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml undiluted UCAR n-pentyl propionate
Duration of treatment / exposure:
approximately one second
Observation period (in vivo):
1 hour, approximately 4 hours, 1 day, 2 days, 3 days and 7 days with additional readings on 14 days and 21 days, if needed
Number of animals or in vitro replicates:
4 male + 2 female
Details on study design:
0.1 ml of UCAR n-pentyl propionate (undiluted) was instilled into the lower conjunctival sac of one eye of 6 New Zealand White rabbits and the eyelids held together about 1 second. The eyes were scored as per Draize method at 1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days after dosing. Additional readings were done on days 14 and 21, if needed. 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:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
There were no signs of eye irritation in the tested rabbits
Other effects:
not applicable

None

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

In this study, the eye irritation potential of undiluted UCAR n-pentyl propionate was evaluated on four male and two female New Zealand White rabbits.

0.1 ml of UCAR n-pentyl propionate (undiluted) was instilled into the lower conjunctival sac of one eye of 6 New Zealand White rabbits and the eyelids held together about 1 second. The eyes were scored as per Draize method at 1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days after dosing. Additional readings were done on days 14 and 21, if needed. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day. There were no signs of eye irritation in the tested rabbits. Under the conditions of the study, UCAR n-pentyl propionate would not be be classified as an eye irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.

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 -

In a non-GLP study conducted following methodology equivalent to OECD TG 404, the mean erythema and edema scores over 6 New Zealand White rabbits exposed to 0.5 ml of pentyl propionate was 0, i.e. no signs of erythema and edema were noted in any of the exposed animals.

Eye irritation -

In a non-GLP study conducted following methodology equivalent to OECD TG 405, the mean corneal, iris, chemosis and conjunctival scores over 6 New Zealand White rabbits exposed to 0.1 ml of pentyl propionate was 0, i.e. no signs of eye irritation were noted in any of the exposed animals.

Respiratory irritation -

The key studies for repeated dose toxicity indicate that irritation of the upper respiratory tract at high concentrations occurs. However the data are not sufficient to lead to a conclusion for classification. In addition, no reports of upper respiratory tract or respiratory irritation have been reported from workers handling the material.

Justification for classification or non-classification

In the absence of any skin, eye or respiratory irritation and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, pentyl propionate will not be classified as a skin or an eye or a respiratory irritant.