Registration Dossier
Registration Dossier
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EC number: 201-167-4 | CAS number: 79-01-6
Repeated dose toxicity: inhalation
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:
- 1 988
- 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
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Trichloroethylene
- EC Number:
- 201-167-4
- EC Name:
- Trichloroethylene
- Cas Number:
- 79-01-6
- Molecular formula:
- C2HCl3
- IUPAC Name:
- trichloroethylene
- Test material form:
- other: vapour
- Details on test material:
- Trichloroethylene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system 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.
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