Registration Dossier
Registration Dossier
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EC number: 203-137-6 | CAS number: 103-71-9
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Seven groups of 5 male and 5 female rats were exposed nose/head only to vapours of 0, 0.7, 5.4, 15.2, 11.7, 27.9, 47.1 or 87.8 mg/m³ (analytical) phenyl isocyanate for 4 hours. The animals were observed for mortality, body weight and clinical signs through day 14. A gross pathological examination was performed on animals which died intercurrent or were killed after termination of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Phenyl isocyanate
- EC Number:
- 203-137-6
- EC Name:
- Phenyl isocyanate
- Cas Number:
- 103-71-9
- Molecular formula:
- C7H5NO
- IUPAC Name:
- isocyanatobenzene
- Details on test material:
- content: 99.9%
Constituent 1
- Specific details on test material used for the study:
- Content: 99.9%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0, 2, 19, 21, 31, 65, 83, 150 (nominal)
0, 0.7, 5.4, 15.2, 11.7, 27.9, 47.1 or 87.8 mg/m³ (analytical) - No. of animals per sex per dose:
- 5 rats/sex/dose
- Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.022 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.019 - <= 0.027
- Exp. duration:
- 4 h
- Mortality:
- Males: 0 (control), 0 (0.7 mg/m³), 0 (5.4 mg/m³), 0 (15.2 mg/m³), 0 (11.7 mg/m³), 3 (27.9 mg/m³), 5 (47.1 mg/m³), 5 (87.8 mg/m³)
Females: 0 (control), 0 (0.7 mg/m³), 0 (5.4 mg/m³), 0 (15.2 mg/m³), 1 (11.7 mg/m³), 4 (27.9 mg/m³), 5 (47.1 mg/m³), 5 (87.8 mg/m³) - Clinical signs:
- other: Beginning at 0.005 mg/l phenyl isocyanate in the test atmosphere a concentration dependent irritation of the respiratory tract und long lasting respiratory discomfort was evident.
- Body weight:
- A significant influence on body weight gain was seen beginning with group 5 (11.7 mg/m³).
- Gross pathology:
- Lungs inflated and edematous. Rhinarium and intestinal mucosa reddened. Spleen, liver and kidneys pale.
- Other findings:
- A delayed mortality occurred. The median of survival was 9 days.
Any other information on results incl. tables
Beginning at 0.005 mg/l phenyl isocyanate in the test atmosphere a concentration dependent irritation of the respiratory tract und long lasting respiratory discomfort was evident. The delayed mortality were caused by an irritative lung damage.
The NOEL was 0.0007 mg/l phenyl isocyanate
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 based on GHS criteria
- Conclusions:
- The LC50 was 0.022 mg/l (rat, male + female). According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Acute Tox. 1 is justified.
- Executive summary:
Seven groups of 5 male and 5 female rats were exposed nose/head only to vapours of 0, 0.7, 5.4, 15.2, 11.7, 27.9, 47.1 or 87.8 mg/m³ (analytical) phenyl isocyanate for 4 hours. The animals were observed for mortality, body weight and clinical signs through day 14. A gross pathological examination was performed on animals which died intercurrent or were killed after termination of the study.
LC50 = 0.022 mg/l (rat, male + female). Beginning at 0.005 mg/l phenyl isocyanate in the test atmosphere a concentration dependent irritation of the respiratory tract und long lasting respiratory discomfort was evident. The delayed mortality was caused by an irritative lung damage.
The NOEL was 0.0007 mg/l phenyl isocyanate.
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