Registration Dossier
Registration Dossier
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EC number: 203-628-5 | CAS number: 108-90-7
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (comparable to guidelines).
Data source
Reference
- Reference Type:
- publication
- Title:
- The inhalation hazard test; principle and method
- Author:
- Klimisch, H.J.
- Year:
- 1 988
- Bibliographic source:
- Arch. Toxicol. 61, 411 - 416
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- : Inhalation Hazard Test (See Annex)
- Deviations:
- yes
- Remarks:
- For each exposure time only 3 animals of each sex were used instead of 5 for each sex. Analytical purity not reported. Housing condition of the animals was not reported.
- GLP compliance:
- not specified
- Test type:
- other: Inhalation Hazard Test
- Limit test:
- no
Test material
- Reference substance name:
- Chlorobenzene
- EC Number:
- 203-628-5
- EC Name:
- Chlorobenzene
- Cas Number:
- 108-90-7
- Molecular formula:
- C6H5Cl
- IUPAC Name:
- chlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): Chlorobenzene
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure system used in conventional inhalation toxicity studies. Two simple all-glass systems with tubes suitable for the exposure of six to ten animals.
- Exposure chamber volume: (V=1-2 L). Flow-through exposure tube (glass).
- System of generating particulates/aerosols: A glass flask generator was used for generation of a vapor saturated inhalation atmosphere
- Temperature, humidity, pressure in air chamber: 20 °C , no more data
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- was determined gravimetrically from the weight loss of the material and the volume of air passing through the generator.
- Duration of exposure:
- >= 0.17 - <= 1.8 h
- Concentrations:
- 66 mg/L (nominal concentration)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- no data
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- other: LT0
- Effect level:
- 66 mg/L air
- Exp. duration:
- 0.17 h
- Remarks on result:
- other: LT0= exposure time after which no animals died within 14 days.
- Sex:
- male/female
- Dose descriptor:
- other: LT50
- Effect level:
- 66 mg/L air
- Exp. duration:
- 1.8 h
- Remarks on result:
- other: exposure time after which 50% of the animalss died within 14 days.
- Mortality:
- no data
- Clinical signs:
- other: no data
- Body weight:
- no data
- Gross pathology:
- no data
Any other information on results incl. tables
The LC50 was calculated by the applicant according to the Haber´s rule ( Haber F, 1924. Fünf Vorträge aus den Jahren 1920 -1923, Verlag von Julis Springer) :
c x t = constant; t= LT50/normal exposure period
66 mg/L *1.8h/4h= 29.7 mg/L.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Executive summary:
Klimisch H.J., 1988.
The Inhalation Hazard Test was performed to determine the hazard of volatile substances in general and chlorobenzene in particular. Glass flask generator was used for the generation of a vapor saturated inhalation atmosphere. The exposure system used was made of two simple glass systems with tubes for the exposure of six to ten animals. 3 male and 3 female rats have been exposed to 66 mg/L (nominal concentration) and LT0 (time T after which no animals died within 14 days of post-exposure observation period) and LT50 (time of exposure after which 50% of the animals died within 14 days of the post-exposure observation period) were calculated
LT0 was estimated to be 0.17 h. LT 50 value was calculated from IHT results. LT50=1.8 h.
The LC50 was calculated by the applicant according to the Haber´s rule: LC50= 66
(1.8/4)*= 29.7 mg/L.
The study was performed according to OECD guideline 403 with deviations (For each exposure time only 3 animals of each sex were used instead of 5 for each sex. Analytical purity not reported. Housing condition of the animals was not reported).
The study was considered as reliable with restrictions.
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