sec-butylamine

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

No studies are available for sec-Butyllamine, however 3 studies was performed with the analogue monoisopropylamine and used for read across to sec-Butylamine (see justification for read across document section 7.5.2 , 7.8.1 and 7.8.2). The purpose of these studies was to examine the toxicity of inhaled isopropylamine (MIPA) in Sprague-Dawley rats and their offspring.

This project consisted of three studies: a male fertility study, a female reproduction study, and a subchronic toxicity study.

Animals in these three studies were exposed concurrently.

In the fertility and reproduction studies performed according to OECD 415, four groups of 20 male and 25 female rats each were exposed for 6 hrs/day, 5 days/wk

(except holidays) for approximately 10.5 weeks. Each exposed male was then consecutively cohoused (1:1) with two unexposed females;

exposed females were cohoused (1:1) with unexposed males. Treated males and females were exposed during the mating period

(5 days/wk). Once mating occurred, treated females were exposed 7 days/wk through gestation day 20. Untreated female mates

of exposed males were terminated approximately two weeks after copulation to assess fertility. Exposed females were housed in delivery boxes and delivered their pups. Pups were weaned on lactation Day 21 and necropsied. Mean analytical exposure concentrations were 20, 100, and 499 mg IPA per cubic meter. The mean body weight of exposed high level males was significantly reduced throughout most of the study. There were no treatment-related effects on mating, fertility,or reproduction parameters in exposed males or females. No gross or microscopic pathology changes were noted in FO or F1 animals.

The following information is taken into account for any hazard / risk assessment:

NOAEC = 500 mg/m3: No adverse effect on reproductive performance in the P-generation and no adverse effects on development of the progeny of the P-generation (F1)

Effect on fertility: via inhalation route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEC

499 mg/m³

Study duration:

subchronic

Species:

rat

Quality of whole database:

Reliability 1

Effects on developmental toxicity

Description of key information

No developmental study is performed with sec-Butylamine. However read across approach was applied with a study conducted in a manner equivalent or similar to OECD Guideline 414 (Prenatal Developmental Toxicity Study) with the analogue isopropylamine (see section 7.8.2). Groups of 25 female Sprague-Dawley rats were exposed by whole body vapor inhalation to isopropylamine at 50, 500 or 1000 mg/m³on gestation days 6-15 (Kier and Thake, 1988). Embryonal and fetal development was not impaired following inhalation exposure of pregnant rats to high levels of isopropylamine. Maternal toxicity was observed at 1000 mg/m³, based on effects on bodyweight, treatment-related clinical signs (nasal discharge, rales, labored breathing, sneezing and fur staining/encrustation) and macroscopically observed reduced abdominal fat. The NOAEC (maternal) was 500 mg/m³, and the NOAEC (offspring) was 1000 mg/m^3.

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEC

500 mg/m³

Study duration:

subacute

Species:

rat

Quality of whole database:

Reliability 1

Justification for classification or non-classification

Classification is not warranted.