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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
repeated dose toxicity: inhalation
Remarks:
combined repeated dose and carcinogenicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Klimisch code: 1. Reliable without restrictions. “Key study” Well-defined, GLP compliant study.

Data source

Reference
Reference Type:
publication
Title:
Long-term carcinogenicity bioassays on trichloroethylene administered by inhalation to Sprague-Dawley rats and Swiss and B6C3F1 mice.
Author:
Maltoni et al
Year:
1988
Bibliographic source:
Ann N Y Acad Sci, Jan 1988; 534: 316-342

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
Principles of method if other than guideline:
Repeated Dose Inhalation Toxicity Study
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: vapour
Details on test material:
Trichloroethylene

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:12-13 weeks
- Weight at study initiation: no data
- Fasting period before study:no data
- Housing:no data
- Diet (e.g. ad libitum):no data
- Water (e.g. ad libitum):no data
- Acclimation period:no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C):no data
- Humidity (%):no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light):no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:Whole body inhalation chamber exposure to test substance vapour.
- Method of holding animals in test chamber: no data
- Source and rate of air:no data
- Method of conditioning air:no data
- System of generating particulates/aerosols:no data
- Temperature, humidity, pressure in air chamber:no data
- Air flow rate:no data
- Air change rate:12 -15 per hour
- Treatment of exhaust air:no data

TEST ATMOSPHERE
- gas chromatographic monitoring
Duration of treatment / exposure:
8 weeks
Frequency of treatment:
7 h/day, 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100 or 600 ppm
Basis:

No. of animals per sex per dose:
60 -90/sex/dose group
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No data
- Time schedule for examinations:

Sacrifice and pathology:
GROSS PATHOLOGY: Yes Complete necropsies were performed on all animals

HISTOPATHOLOGY: Yes (see below)
Histologic examination included the following organs and tissues: skin, mammary glands, subcutaneous lymph nodes, brain, cerebellum, pituitary, eyeballs, Zymbal glands, interscapular brown fat, salivary glands, Harderian glands, thyroid, tongue, thymus, mediastinal lymph nodes, larynx, lungs, heart, aorta, esophagus, diaphragm, liver, spleen, pancreas, kidneys, adrenals, mesenteric lymph nodes, stomach, various segments of the intestine, seminal vesicles, prostate gland, uterus, gonads, right thigh muscle, bone marrow (smear of the femur), and any other organs with pathologic lesions.

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Results

NOAEC = 600 ppm

 

Mortality:

No treatment-related mortality was observed.

Body weight:

No treatment-related effects on body weight were observed.

 

Histopathology incidence and Carcinogenicity:

No treatment-related effects on the incidence of expected tumors were observed. No unexpected type of tumors were observed

Applicant's summary and conclusion

Conclusions:
Remarks (submitter comment):
In the present study, NOAEC = 600 ppm.