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Description of key information

Acute oral - In a non-GLP study conducted with study methodology equivalent to OECD TG 401, the LD50 value of pentyl propionate to male and female Sprague Dawley rats was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)).
Acute dermal - In a non-GLP study conducted with study methodology equivalent to OECD TG 402, the acute dermal LD50 value of pentyl propionate to male and female New Zealand rabbits was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)).
Acute inhalation - In a non-GLP study conducted with study methodology equivalent to OECD TG 403, the acute inhalation LC50 value of pentyl propionate to male and female Sprague Dawley rats exposed to saturated vapors over a period of 6 hours was 10070 mg/m3 or 10.07 mg/l (based on conversion).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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 401 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 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 200-300 grams
- Fasting period before study: overnight fasting before dosing
- Housing: group housed
- Diet (e.g. ad libitum): commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The animals are administered the test material by stomach intubation with a ball-end stainless steel needle. The samples are adminsitered through the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution.
Doses:
16 and 8 ml/kg
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and animals were weighed on days 0, 7 and 14 of the study
- Necropsy of survivors performed: yes
Statistics:
LD50 and the estimated LD50 slopes were calculated by the moving average method
Preliminary study:
not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)
Mortality:
Males - 2 out of 5 animals were found dead on day 1 and
Females - 1 out 5 animal was found dead on day 2
Clinical signs:
Males - Unsteady gait was noted at 1.5 hours post dosing; sluggishness (marked in 2 rats) at 2.0 hours and red crust on perinasal fur at day 1. Brown stain on perigenital fur was noted in 2 rats at day 1. Survivors recovered around 2-3 days.
Females - Sluggishness, unsteady gait (marked in 2 rats) was noted at 2.0 hours post dosing and survivors recovered around 1-2 days.
Body weight:
Body weight gain was noted in all surviving animals of the treated dose groups
Gross pathology:
In those animals found dead changes such as mottling of lungs and kidneys, liquid and gas filled stomach were noted, while in the surviving animals there were no changes noted attributable to test material administration.
Other findings:
None

Conversion of values from ml/kg to mg/kg resulted in -

16 ml/kg - 13920 mg/kg and 8 ml/kg - 6960 mg/kg (based on density of 0.87)

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the oral LD50 of the UCAR n-pentyl propionate to Sprague Dawley rats was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
Executive summary:

Groups of 5 male and 5 female Sprague Dawley rats (adults, weighing between 200-300 grams) were administered UCAR n-pentyl propionate (undiluted) at doses of 16 and 8 ml/kg and observed for mortality and clinical signs of toxicity for 14 days. Two of 5 male rats and one of 5 female rats died after receiving peroral doses of 16.0 ml/kg of N-pentyl propionate. None of 5 male or 5 female rats died from a dosage of 8.0 ml/kg. Signs of toxicity included sluggishness (marked in some), an unsteady gait and red to brown staining on the perinasal or periurogenital fur. Deaths occurred at one to 2 days. Survivors recovered at one to 3 days. Necropsy of victims revealed mottled and dark red lungs (in one); stomachs filled with gas and/or clear liquid; red, white and/or grey stomachs; red intestines (in one); mottled and grey kidneys; and one bladder distended with clear to yellow liquid. No remarkable gross lesions were evident in survivors. Under the conditions of the study, the oral LD50 of the UCAR n-pentyl propionate to Sprague Dawley rats was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
marvellous

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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 403 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 403 (Acute Inhalation Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 200-300 grams
- Fasting period before study: overnight fasting before dosing
- Housing: group housed
- Diet (e.g. ad libitum): commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
Sprague-Dawley rats were exposed to substantially saturated vapor for 6 hours. The vapor was produced by enclosing approximately 100 grams of the test material in a sealed 100-151 liter animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in distribution of the vapor. Oxygen was added as needed to maintain a chamber oxygen content of approximately 20%.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
6 h
Concentrations:
substantially saturated vapor concentration
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and weights recorded weekly
- Necropsy of survivors performed: yes
Statistics:
LD50 and the estimated LD50 slopes were calculated by the moving average method
Preliminary study:
not applicable
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 10.07 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Conversion of a substantially saturated vapor exposure to mg/l
Mortality:
None noted
Clinical signs:
other: None noted
Body weight:
Body weight noted in all the animals of the treated group
Gross pathology:
No gross pathological changes attributable to exposure were noted
Other findings:
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, no mortality was noted in Sprague Dawley rats exposed to substantially saturated vapor levels of UCAR n-pentyl propionate (LC0 greater than 10.07 mg/l; converted value) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
Executive summary:

In this study, groups of 5 male and 5 female Sprague Dawley rats (adults, weighing between 200 -300 grams) were exposed to substantially saturated vapors of UCAR n-pentyl propionate for 6 hours. The vapor was produced by enclosing approximately 100 grams of the test material in a sealed 100-151 liter animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in distribution of the vapor. Oxygen was added as needed to maintain a chamber oxygen content of approximately 20%. There were no mortalities, clinical signs of toxicity and gross pathological signs noted at the end of the study. Body weight gain was noted in all the exposed animals. Under the conditions of the study, no mortality was noted in Sprague Dawley rats exposed to substantially saturated vapor levels of UCAR n-pentyl propionate (LC0 greater than 10.07 mg/l; converted value) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
marvellous

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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 402 and the report contains suffficient 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 402 (Acute Dermal Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
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
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
New Zealand White rabbits were subjected to 24 hours of contact with the test material retained under impervious sheeting on the clipped, intact skin of the trunk. For larger doses, gauze was wrapped around the trunk over the sample to prevent leakage. Vetrap bandaging tape was wrapped over the impervious sheeting and the animal returned to its cage for the contact period. After the contact period, excess fluid was removed to prevent accidental ingestion.
Duration of exposure:
assumed to be 1 hour
Doses:
16 ml/kg
No. of animals per sex per dose:
5 male + 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for skin reactions and body weights - 1 hour, 7 days and 14 days
- Necropsy of survivors performed: yes
Statistics:
LD50 and the estimated LD50 slopes are estimated by the moving average method
Preliminary study:
not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)
Mortality:
None
Clinical signs:
None noted in males while in females one animal appeared emaciated with distended abdomen and diarrhoea.
Body weight:
All animals appeared to gain weight at 14 days
Gross pathology:
No gross pathological changes attributable to exposure were noted
Other findings:
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, the dermal LD50 of the UCAR n-pentyl propionate to New Zealand White rabbits was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
Executive summary:

In this dermal study, a group of 5 male and 5 female New Zealand rabbits (adults, weighing between 2.0 -3.0 kg) were exposed to 16 ml/kg of UCAR n-pentyl propionate under occlusive conditions and observed for 14 days for mortality and signs of toxicity. There were no mortalities noted and clinical signs of toxicity were limited to 1 female animal which appeared to be emaciated with distended abdomen and diarrhoea. Under the conditions of the study, the dermal LD50 of the UCAR n-pentyl propionate to New Zealand White rabbits was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
marvellous

Additional information

Acute oral -

In a non-GLP study conducted with study methodology equivalent to OECD TG 401, the acute oral LD50 value of pentyl propionate to male and female Sprague Dawley rats was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)).

Acute dermal -

In a non-GLP study conducted with study methodology equivalent to OECD TG 402, the acute dermal LD50 value of pentyl propionate to male and female New Zealand rabbits was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)).

Acute inhalation -

In a non-GLP study conducted with study methodology equivalent to OECD TG 403, the acute inhalation LC50 value of pentyl propionate to male and female Sprague Dawley rats exposed to saturated vapors over a period of 6 hours was > 10070 mg/m3 or 10.07 mg/l (based on conversion). This was the highest concentration atainable and produced no lethality.


Justification for classification or non-classification

Based on the acute oral, dermal and inhalation LD/LC50 values noted 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 for acute toxicity via oral, dermal and inhalation routes of exposure.