2,3-epoxypropyl phenyl ether

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Although this study was not conducted in accordance with current international guidelines or GLP, in accordance with REACH Annex XI, Section 1.1.2, the study was conducted under sound scientific principles of chromosome aberration assessment and adequate documentation of the study is provided. The study is therefore considered adequate for fulfilling this endpoint and for risk assessment purposes.

Data source

Reference

Reference Type:

publication

Title:

The inhalation toxicity of phenylglycidyl ether: Reproduction, mutagenic, teratogenic and cytogenetic studies

Author:

James B. Terrill

Year:

1982

Bibliographic source:

Terrill, J. B., Lee, K. P., Culik, R., and Kennedy Jr, G.L. (1982) The inhalation of phenylglycidyl ether: Reproduction, mutagenic, teratogenic, and cytogenetic studies. Toxicology and Applied Pharmacology, 64:204-212.

Materials and methods

Principles of method if other than guideline:

Although this study was not conducted in accordance with current international guidelines or GLP, in accordance with REACH Annex XI, Section 1.1.2, the study was conducted under the scientific principles of an in-vivo chromosome abberration study and adequate documentation of the study is provided. The study is therefore considered adequate for fulfilling this endpoint and for risk assessment purposes.

GLP compliance:

no

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropyl phenyl ether

EC Number:

204-557-2

EC Name:

2,3-epoxypropyl phenyl ether

Cas Number:

122-60-1

Molecular formula:

C9H10O2

IUPAC Name:

2-(phenoxymethyl)oxirane

Details on test material:

PGE purity was 99.6 % with trace amounts of phenol and diglycidyl ether as determined by gas chromatography.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

inhalation: vapour

Details on exposure:

The test atmosphere was generated by syringe-driving unheated liquid into a tube furnace. The furnace tube (2 in. i.d. x 24 in. length, stainless steel) was constructed in such a way that the wall temperature of the delivery tube and the pure nitrogen stream (10 L/min) were the same temperature, 310 degrees celsius. The nitrogen-PGE atmosphere was delivered directly to the exposure chamber.
Exposures were run in 5 cubic metre chambers. Satisfactory chamber temperature (< 32 degrees celsius) and oxygen levels were maintained by the 2000 L/min inlet air velocity.

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
1.75 ± 0.2 ppm TWA
Basis:
analytical conc.

Doses / concentrations 2

Remarks:

Doses / Concentrations:
5.84 ± 0.7 ppm TWA
Basis:
analytical conc.

Doses / concentrations 3

Remarks:

Doses / Concentrations:
11.2 ± 2.8 ppm TWA
Basis:
analytical conc.

Control animals:

yes

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Additional information on results:

No increase in the incidence of gaps, breaks, or rearrangements were observed among rats exposed to PGE (Table 1). All cells studied showed the most common chromosome number for this taxonomic group, 42. Gaps were scored as achromatic lesions in one or both chromosomes with no visible structural break and were not considered as true aberrations. Breaks were counted where true structural discontinuities in chromatids or chromosomes were observed. Rearrangements were defined as visible, chromosomal structural changes.

Any other information on results incl. tables

Table 1. Chromosomal studies of bone marrow cells - rats exposed to PGE

Group exposure (ppm)	Cells examined^a	Cells with
		Gaps	Breaks	Rearrangement	>10 Aberrations	Cells with aberrations^b
0	341	21 (6.1)	23 (6.7)	3 (0.9)	1 (0.3)	27 (7.9)
2	300	18 (6.0)	14 (4.7)	4 (1.3)	1 (0.3)	19 (6.3)
6	304	24 (7.9)	10 (3.3)	1 (0.7)	0 (0)	11 (3.3)
11	304	22 (7.3)	21 (7.0)	4 (1.3)	0 (0)	25 (8.2)

a - At least 50 cells studies in each of six rats

b - Excludes gaps

Parentheses = %

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Rats exposed to atmospheres of up to 11 ppm PGE showed no significant abnormalities in this cytogenetic evaluation.