Registration Dossier
Registration Dossier
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EC number: 201-166-9 | CAS number: 79-00-5
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Results issued from reviewed document but only brief summary was available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2002
Materials and methods
- Principles of method if other than guideline:
- Not reported
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,1,2-trichloroethane
- EC Number:
- 201-166-9
- EC Name:
- 1,1,2-trichloroethane
- Cas Number:
- 79-00-5
- Molecular formula:
- C2H3Cl3
- IUPAC Name:
- 1,1,2-trichloroethane
- Details on test material:
- Name of the test substance (as cited in the test report) : 1,1,2-trichloroethane.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 6 months (chronic study)
- Frequency of treatment:
- 7 h/d, 5 d/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15 ppm or 83 mg/m3 (calculated daily dose; 11.1 mg/kg bw/day)
Basis:
no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- not specified
- 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:
- not specified
- Details on results:
- No substance-related histopathological, hematological and biochemical changes were observed. Body weight gain, organ weights and mortality
remained unaffected.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 11.1 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No substance-related histopathological, hematological and biochemical changes were observed. Body weight gain, organ weights and mortality remained unaffected.
- Dose descriptor:
- NOAEC
- Effect level:
- 83 mg/m³ air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No substance-related histopathological, hematological and biochemical changes were observed. Body weight gain, organ weights and mortality remained unaffected.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Repeated inhalation exposure (7 hours/day, 5 days/week) of rat to 83 mg of 1,1,2-trichloroethane/m3 air for 6 months did not lead to any substance-related effects. Therefore, NOAEC was considered to be 83 mg/m3, equivalent to a NOAEL of roughly 11.1 mg/kg bw/day in rat.
- Executive summary:
Repeated inhalation exposure (7 hours/day, 5 days/week) to 83 mg of 1,1,2-trichloroethane/m3 air for 6 months did not lead to substance-related histopathological, hematological and biochemical changes in rat. Body weight gain, organ weights and mortality remained unaffected. Therefore, NOAEC was considered to be 83 mg/m3, equivalent to a NOAEL of roughly 11.1 mg/kg bw/day in rat.
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