Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Original publication in Czech; only few data could be extracted from an English abstract and from tables; However, peer reviewed data used as supporting data for HPV submission (US EPA); Scientifically acceptable.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Mutagenic and gonadotoxic properties of trioxane and dioxolane
Author:
Baranski B et al.
Year:
1984
Bibliographic source:
Med Pr 35: 245-255
Reference Type:
secondary source
Title:
1,3,5-TRIOXANE, CAS Number 110-88-3, USEPA HPV Challenge Program Submission
Author:
Trioxane Manufacturers Consortium Members, BASF Performance Copolymers, LLC (Formerly Ultraform Company) and Ticona
Year:
2000
Bibliographic source:
USEPA HPV Submission

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Test conduct was similar to OECD Guideline 478; the study was a combination between Dominant lethal assay and Fertility study.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-trioxane
EC Number:
203-812-5
EC Name:
1,3,5-trioxane
Cas Number:
110-88-3
Molecular formula:
C3H6O3
IUPAC Name:
1,3,5-trioxane
Details on test material:
Trioxane
No further data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Designation: albino Wistar rats
Source: no data
Age at test initiation: 3.5 to 4 months old
Body weight at test initiation: 300 to 320

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: air
Details on exposure:
- Males only were treated with the test substance by inhalation over a period of 12 months;
- The concentration of test material was measured by chromatography;
- Mating was conducted during one week at the end of the treatment period;
- Mating ratio was 2 untreated females: 1 treated male;
- The treated males were observed and examined for mortality and clinical symptoms of toxicity, and body weights were recorded;
- At test ending, the males were sacrificed for the purpose of necropsy; particular attention was given to the reproductive organs;
- Dams were sacrificed 13-14 days after the middle of mating intervals;
- The number of pregnant dams, live fetuses, dead implants, total implants, pre-implantation losses and corpora lutea were considered as parameters for the assessment of a dominant lethal effect, which was the main aim of present study.
Details on mating procedure:
- Mating was conducted during one week at the end of the treatment period;
- Mating ratio was 2 untreated females: 1 treated male;
- The treated males were observed and examined for mortality and clinical symptoms of toxicity, and body weights were recorded;
- At test ending, the males were sacrificed for the purpose of necropsy; particular attention was given to the reproductive organs;
- The number of pregnant dams, live fetuses, dead implants, total implants, pre implantation losses and corpora lutea were considered.
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
12 months
Frequency of treatment:
5 hours/day
Five days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 2500 mg/m3 (i.e. 0.25 mg/l)
Basis:

No. of animals per sex per dose:
14 animals were used
Control animals:
yes, concurrent vehicle

Examinations

Statistics:
Kruskal-Wallis Test followed by non-parametric tests for groups with and without normal distribution

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

- Histopathology of the testes revealed no differences between control and treated animals with regard to Leydig cells; seminiferous tubule pathology was not reported;
- All considered reproductive parameters (number of pregnant dams, live fetuses, dead implants, total implants, pre implantation losses and corpora lutea) were inconspicuous, i.e., without treatment-related changes;
- No mortalities were observed;
- No data on clinical symptoms of toxicity and body weight were reported;
- No data on organ weights were reported.

Effect levels (P0)

Dose descriptor:
NOAEC
Remarks:
Fertility
Effect level:
0.25 mg/L air
Sex:
male
Basis for effect level:
other: Assuming a 270 ml/min volume, a mean body weight of 350 g and 100% absorption, the test concentration of 0.25 mg/l corresponded to a dosage of 580 mg/kg bw/day.
Remarks on result:
other: Generation not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

The prolonged exposure of male rats to 0.25 mg/l air of  Trioxane did not affect the fertility of males.
No histopathological changes in the testes were reported.

Applicant's summary and conclusion