Hexylamine

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2005-10-12 through 2007-07-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study Please refer to section 13 (read across statement).

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Reference 2

Reference Type:

other: TSCA 8(e)

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Deviations:

no

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octylammonium chloride

EC Number:

205-574-8

EC Name:

Octylammonium chloride

Cas Number:

142-95-0

IUPAC Name:

octan-1-aminium chloride

Constituent 2

Reference substance name:

octyl ammoniumchloride

IUPAC Name:

octyl ammoniumchloride

Test animals

Species:

rat

Strain:

other: Crl:CD (SD) IGS

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on mating procedure:

- M/F ratio per cage: 1:1
- Length of cohabitation: 14 days
- Proof of pregnancy: sperm in vaginal smear; referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged (how): singly

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

Males 47-48 days; females 42-46 days

Details on study schedule:

- Age at mating of the mated animals in the study: 13 weeks

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 37.5, 75, 100/150 mg/kg bw/day
Basis:
analytical conc.

No. of animals per sex per dose:

12

Control animals:

yes, concurrent vehicle

Examinations

Statistics:

no data

Reproductive indices:

reproductive function calculations (see below)

Offspring viability indices:

Number of live / dead pups at birth; sex ratio; viability at day 4 post partum
Pup clinical observations
Pup weight at birth and at day 4 post partum

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Body weight and weight changes:

not examined

Food consumption and compound intake (if feeding study):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Histopathological findings: non-neoplastic:

not examined

Other effects:

no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

no effects observed

Reproductive function: sperm measures:

not examined

Reproductive performance:

no effects observed

Effect levels (P0)

1

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day (actual dose received)

Sex:

male

Basis for effect level:

other: see 'Remark'

2

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day (actual dose received)

Sex:

female

Basis for effect level:

other: see 'Remark'

Results: F1 generation

General toxicity (F1)

Clinical signs:

no effects observed

Mortality / viability:

no mortality observed

Body weight and weight changes:

not examined

Sexual maturation:

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings:

not examined

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

100 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: clinical signs; mortality; body weight live birth index; litter size; pup weight; sex ratio; survival index;

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

There was no statistically significant change in any of the dose groups compared to the control group in any of the parameters examined in the parental animals or in the offspring.