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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: dominant lethal assay
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guidleline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Rodent dominant lethal assay, antifertility and germ cell mutation (equivalent or similar to OECD 478)
Principles of method if other than guideline:
Rodent dominant lethal study: antifertility and germ cell cell mutation assay.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Vehicle:
unchanged (no vehicle)
Frequency of treatment:
6 hours /day for 5 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 10000, 50000 ppm
Basis:

No. of animals per sex per dose:
15 males / 30 Females
Control animals:
yes, concurrent no treatment

Results and discussion

Results: P0 (first parental animals)

Reproductive function / performance (P0)

Reproductive function: sperm measures:
no effects observed

Effect levels (P0)

Key result
Dose descriptor:
NOEL
Effect level:
50 000 ppm
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No effects on reproductive performance of male mice

Results: F1 generation

Effect levels (F1)

Dose descriptor:
other:
Remarks on result:
not measured/tested

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
50 000 ppm

Applicant's summary and conclusion

Conclusions:
HFC 134a did not affect male fertility or cause mutagenic effects through sperm
Executive summary:

In a dominant lethal assay, CD1 male mice were exposed to up to 50000 ppm HFC 134a for 5 days. After the last exposure, each male was housed with 2 virgin females for 4 consecutive nights. Further matings with new females were conducted at weekly intervals for a total of 8 times. The study indicated that HFC 134a did not affect male fertility or cause mutagenic effects through sperm.