Butyl propionate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no other reproduction toxicity studies available for Butyl propionate

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEC

2 411 mg/m³

Study duration:

subchronic

Species:

rat

Quality of whole database:

good

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

There are no reproduction toxicity studies available for butyl propionate, however there is a reproduction/developmental toxicity study for propyl propionate and a 90-days repeated dose toxicity study available for n-butyl propionate.

Reproduction toxicity data on n-propyl propionate:

In a reproduction/developmental toxicity screening study (OECD TG 422) available, exposure to n-propyl propionate resulted in slight reductions in food consumption and body weight throughout the study in females exposed to 250 and 500 ppm. Treatment related histopathologic effects were also evident in the nasal tissues of males and females exposed to all test concentrations. The nasal tissue effects consisted of very slight degeneration of the olfactory epithelium. In addition males exposed to 500 ppm and females exposed to ≥ 50 ppm had a higher incidence of adipose tissue atrophy than the controls. This was interpreted to have questionable significance. No treatment-related effects were seen in reproductive performance, pup survival and growth, neurologic function, clinical chemistry, or hematology. Therefore, the low-observed-effect concentration (LOEC) for general toxicity for male and female rats was considered to be 500 ppm and the NOEC for reproductive effects and neurological function was 500 ppm (2411 mg/m3), the highest concentration tested.

Reproduction toxicity data on n-butyl propionate:

There are no reproduction toxicity studies available for n-butyl propionate and in aGLP study conducted according to EPA OTS 798.2450 (90 -day Inhalation Toxicity), where groups of male and female Sprague Dawley rats were exposed (whole body) to vapours of butyl propionate over a period of 13 weeks at levels of 250, 750 and 1500 ppm for 6 hours/day, 5 days/week, there were no effects noted in organs (testes, ovaries) of the male and female reproductive system. (refer to repeted dose toxicity section)

Conclusion:

 

In all the available studies on category members there is an absence of any (or any significant) reproduction toxicity . Therefore, it is concluded that butyl propionate is unlikely to cause any reproduction toxicity.

Effects on developmental toxicity

Description of key information

There is an inhalation developmental toxicity study available for butyl propionate.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEC

10 808 mg/m³

Study duration:

subacute

Species:

rat

Quality of whole database:

good

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

There is an inhalation developmental toxicity studies available for butyl propionate.

In a GLP study conducted according to EPA OTS 798.4900 (Prenatal Developmental Toxicity Study), groups of Sprague Dawley rats were exposed (whole body) via inhalation to vapours of butyl propionate at levels of 500, 1000 and 2000 ppm for 6 hours/day, 10 consecutive days (gestation days 6-15). Based on effects on body weight and food consumption observed at exposure concentrations, a NOAEL (no observed adverse effect level) for maternal toxicity was not determined. The exposure concentration of 500 ppm was considered to be the LOAEL (lowest observed adverse effect level) for maternal toxicity. Alternatively, no treatment-related developmental toxic effects were noted for the three tested exposure concentrations. Therefore, the highest exposure 2000 ppm, was considered to be the NOAEL for developmental toxicity.

In a GLP study conducted according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), groups of male and female Crl:CD(SD) rats were exposed via inhalation (whole body) to vapours of propyl propionate at levels of 0, 250, 500 and 1000 ppm for 6 hours/day, 7 days/week for a period of approximately 6-8 weeks.Treatment related histopathologic effects were also evident in the nasal tissues of males and females exposed to all test concentrations. The nasal tissue effects consisted of very slight degeneration of the olfactory epithelium. No treatment-related effects were seen in reproductive performance, pup survival and growth, neurologic function, clinical chemistry, or hematology. Therefore, the low-observed-effect concentration (LOEC) for general toxicity for male and female rats was considered to be 500 ppm and the NOEC for reproductive effects and neurological function was 500 ppm, the highest concentration tested.

 

On the basis of the studies conducted it can be concluded that pentyl propionate is unlikely to cause any developmental toxicity.

Compound tested	Species tested	Duration of exposure	GLP status	Doses tested	Guideline	Result - Maternal toxicity	Result - Developmental toxicity
Butyl propionate	SD rats	GD 6-15, 6 hours/day	Yes	0, 500, 1000, 2000 ppm	EPA OTS 798.4900	LOAEL – 500 ppm	NOAEL – 2000 ppm
Propyl propionate	SD rats	Approximately 6-8 weeks	Yes	0, 250, 500, 1000 ppm	OECD 422	LOEC – 500 ppm	NOEC – 500 ppm

Developmental toxicity data on n-butyl propionate:

In this GLP study conducted according to EPA OTS 798.4900 (Prenatal Developmental Toxicity Study), groups of Sprague Dawley rats were exposed (whole body) via inhalation to vapours of butyl propionate at levels of 500, 1000 and 2000 ppm for 6 hours/day, 10 consecutive days (gestation days 6-15). Based on effects on body weight and food consumption observed at exposure concentrations, a NOAEL (no observed adverse effect level) for maternal toxicity was not determined. The exposure concentration of 500 ppm was considered to be the LOAEL (lowest observed adverse effect level) for maternal toxicity. Alternatively, no treatment-related developmental toxic effects were noted for the three tested exposure concentrations. Therefore, the highest exposure 2000 ppm, was considered to be the NOAEL for developmental toxicity.

Developmental toxicity data on n-propyl propionate:

In a reproduction/developmental toxicity screening study (OECD TG 422) available, exposure to n-propyl propionate resulted in slight reductions in food consumption and body weight throughout the study in females exposed to 250 and 500 ppm. Treatment related histopathologic effects were also evident in the nasal tissues of males and females exposed to all test concentrations. The nasal tissue effects consisted of very slight degeneration of the olfactory epithelium. In addition males exposed to 500 ppm and females exposed to ≥ 50 ppm had a higher incidence of adipose tissue atrophy than the controls. This was interpreted to have questionable significance. No treatment-related effects were seen in reproductive performance, pup survival and growth, neurologic function, clinical chemistry, or hematology. Therefore, the low-observed-effect concentration (LOEC) for general toxicity for male and female rats was considered to be 500 ppm and the NOEC for reproductive effects and neurological function was 500 ppm, the highest concentration tested.

 

Conclusion:

There is an absenceof any developmental toxicity based on the available study with butyl propionate, as well as a lack of developmental toxicity on a second catgegory substances. Therefore, it is concluded that butyl propionate is unlikely to cause any developmental toxicity.

Justification for selection of Effect on developmental toxicity: via inhalation route:
Key study on a category member

Toxicity to reproduction: other studies

Additional information

There are no other reproduction toxicity studies available for pentyl propionate.

Justification for classification or non-classification

In the absence of any effects observed in the reproduction screening test for propyl propionate and the developmental toxicity test for butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, butyl propionate will not be classified for reproduction and developmental toxicity.