Propane, 1,1,1,3,3-pentafluoro-

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

Type of information:

experimental study

Adequacy of study:

key study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)

Deviations:

yes

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.3800 (Reproduction and Fertility Effects)

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

gas

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure (if applicable):

nose/head only

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Effect levels (P0)

Key result

Dose descriptor:

NOAEC

Effect level:

2 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

clinical signs

mortality

body weight and weight gain

neuropathology

histopathology: non-neoplastic

reproductive function (sperm measures)

Target system / organ toxicity (P0)

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

10 000 ppm

System:

cardiovascular

Organ:

brain

heart

kidney

liver

Treatment related:

yes

Dose response relationship:

yes

Relevant for humans:

yes

Results: P1 (second parental generation)

Effect levels (P1)

Key result

Dose descriptor:

NOAEC

Effect level:

10 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

mortality

neuropathology

Target system / organ toxicity (P1)

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

50 000 ppm

System:

central nervous system

Organ:

brain

Treatment related:

yes

Dose response relationship:

yes

Relevant for humans:

yes

Results: F1 generation

Effect levels (F1)

Key result

Dose descriptor:

NOAEC

Generation:

F1

Effect level:

10 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

body weight and weight gain

organ weights and organ / body weight ratios

Target system / organ toxicity (F1)

Key result

Critical effects observed:

no

Results: F2 generation

Effect levels (F2)

Key result

Dose descriptor:

NOAEC

Generation:

F2

Effect level:

10 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

mortality

organ weights and organ / body weight ratios

Target system / organ toxicity (F2)

Key result

Critical effects observed:

no

Overall reproductive toxicity

Key result

Reproductive effects observed:

yes

Lowest effective dose / conc.:

10 000 ppm

Treatment related:

yes

Relation to other toxic effects:

reproductive effects occurring together with other toxic effects, but not as a secondary non-specific consequence of other toxic effects

Dose response relationship:

yes

Relevant for humans:

yes