Carbon tetrafluoride

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

other: QSQR Toolbox

Title:

Unnamed

Year:

1977

Materials and methods

Principles of method if other than guideline:

A group of 20 male and 20 female rats were exposed 6 hours/day for 90 days to 0 or 10000 ppm FKW 23 (also known as HFC-23). The following parameters were assessed: feces, food and water consumption, body weight gain, haematology, clinical biochemistry, urinalysis, sight, hearing, and dentition. Macroscopic and histologic pathologic examinations were performed, including the reproductive organs.

GLP compliance:

no

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Trifluoromethane

EC Number:

200-872-4

EC Name:

Trifluoromethane

Cas Number:

75-46-7

Molecular formula:

CHF3

IUPAC Name:

Trifluoromethane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure (if applicable):

whole body

Vehicle:

air

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

90 days

Frequency of treatment:

6 hours/day

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

10 000 ppm (nominal)

Doses / concentrations 2

Dose / conc.:

0 ppm (nominal)

No. of animals per sex per dose:

20 male and 20 female/concentration

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

1

Dose descriptor:

LOAEL

Effect level:

> 10 000 ppm

Sex:

male/female

Basis for effect level:

other:

2

Dose descriptor:

NOAEL

Effect level:

10 000 ppm (nominal)

Sex:

male/female

Basis for effect level:

other:

Any other information on results incl. tables

Gonads: No pathological findings were noted on the macroscopic examination. Absolute weights were within the normal range.

Microscopic findings in the testicle included: bilateral diffuse atrophy of the canaliculi (one control animal) and bilateral localized atrophy of the canaliculi (15 control animals and 10 test animals) and dyszoospermia (one control animal).

No microscopic findings were noted in the ovaries.

Prostate/Uterus: No macroscopic findings were noted in the prostate and uterus. One control animals had a localized atrophy in the the prostate. No microscopic findings were noted in the uterus.

Spermatocyst/mamma: No macroscopic or microscopic findings were noted.

Applicant's summary and conclusion

Conclusions:

The NOAEL for effects on reproductive organs was 10000 ppm, which was the highest concentration tested.

Executive summary:

In a 90-day inhalation study in the rat, no adverse effects were noted following exposure in the reproductive organ weights or pathology findings.

The objective of this study was to assess the potential subchronic toxicity of the test substance in rats. Two groups of young adult male and female Sprague Dawley rats (20/sex/group) were administered by 0 or 10000 ppm via inhalation, 6 hrs/day, for approximately 90 days. Body weights, food consumption, and detailed clinical observations were evaluated weekly until sacrifice. The animals were

examined daily after dosing for acute clinical signs of systemic toxicity. Hematology endpoints were evaluated at necropsy. Clinical biochemistry endpoints were evaluated before the first exposure, after 7 test days, as well as after 6 and 13 weeks of treatment. Urinalysis examinations were conducted after 13 weeks of treatment. At scheduled necropsy, the rats were sacrificed and given a gross and microscopic pathological examination. No adverse histopathological or weight changes were observed in reproductive organs at any dose level tested.