2,3-epoxypropyl phenyl ether

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientific publications with restrictions compared to Guideline Study (limited documentation)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The inhalation toxicity of phenylglycidyl ether. I. 90-day inhalation study

Author:

James B. Terrill, Ki P. Lee

Year:

1977

Bibliographic source:

Toxicology and Applied Pharmacology, Volume 42, Issue 2, November 1977, Pages 263-269

Reference 2

Reference Type:

publication

Title:

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

Author:

James B. Terrill1, K.P. Lee, Rudolf Culik, Gerald L. Kennedy Jr.

Year:

1984

Bibliographic source:

Toxicology and Applied Pharmacology, Volume 64, Issue 2, 30 June 1982, Pages 204-212

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)

Principles of method if other than guideline:

Scientific publication with limited documentation

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Name: phenylglycidyl ether (PGE)
Purity 99.6 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Charles River
Weight at study initiation. 250 - 260 g (male), 180-200 g (female)
No further data

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

vapour generated from liquid heated to a polymer process temperature of 310°C

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

UV detection (LOQ = 1ppm)

Duration of treatment / exposure:

6 hours

Frequency of treatment:

daily 5 days / week, total 90 days

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
1 (1.3 ± 0.5) ppm
Basis:
analytical conc.

Doses / concentrations 2

Remarks:

Doses / Concentrations:
5 (5 ± 1.32) ppm
Basis:
analytical conc.

Doses / concentrations 3

Remarks:

Doses / Concentrations:
12 (11.8 ± 2.8) ppm
Basis:
analytical conc.

No. of animals per sex per dose:

32 (16 male, 16 female)

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

clinical symptoms: daily
body weight: twice per week
Urinalysis: days 30, 60 and 90 of the study and days 30, 60, and 90 of recovery
Hematology and clinical biochemistry: SGPT, AP, Glucose, hemoglobin, hematikrit, red and white blood cells

Sacrifice and pathology:

On days 30, 60 and 90 of the study and on day 28 of the recovery period, six female and six male rats of each dose group were sacrified and subsequently examined by histopathological investigations

Other examinations:

Organ weights. brain, heart, lungs, liver, kidneys, spleen, thyroid glands, hypophyse, adrenal glands, testis, ovaries,
relative organ weights

Histopathology: lungs, trachea, heart, aorta, spleen, spinal cord, lymph nodes, thorax, liver, stomach, duodenum, jejunum, ileum, ceacum, colon, rectum, pankreas, kidneys, urinary bladder, salivary glands, thyroid glands, adrenal glands, hypophyse, thymus, testis, ovaries, uterus, mammary glands, brain, eyes, N. ischiadicus, skin

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

The only significant finding was patchy, bilateral, hair loss in both male and female rats exposed at the two highest levels. Histopathologic evaluation of the hair loss areas showed varying degrees of damage to the hair follicles with occasional shaft breakage outside the epidermis. Microscopic comparison of 32 other major organs and tissues from test and control animals showed no compound-related effects. Likewise, no differences between test and control groups were seen relative to body weight, hematologic, urinanalytical, or biochemical indices. The hair loss was probably attributable to a mild focal skin irritation from PGE vapor and not to a systemic effect of inhaled PGE.

Effect levels

1

Dose descriptor:

NOAEC

Effect level:

1 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Alopecia (predominantly observed in females)

2

Dose descriptor:

LOAEC

Effect level:

5 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Alopecia

Target system / organ toxicity

Critical effects observed:

not specified