Registration Dossier
Registration Dossier
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EC number: 201-075-4 | CAS number: 78-00-2
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Inhalation of tetramethyllead and tetraethyllead
- Author:
- Davis, R.K., Horton, A.W., Larson, E.E., Stemmer, K.L.
- Year:
- 1 963
- Bibliographic source:
- Archives of Environmental Health Vol 6, pp 473-479
Materials and methods
- Principles of method if other than guideline:
- In a series of experiments, rats and dogs inhaled various concentrations of TEL according to an intermittent schedule of hours and days. The animals were oberved for 35 weeks for evidence of toxic responses
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetraethyllead
- EC Number:
- 201-075-4
- EC Name:
- Tetraethyllead
- Cas Number:
- 78-00-2
- Molecular formula:
- C8H20Pb
- IUPAC Name:
- tetraethylplumbane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFN
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were confined in 32 litre glass cages, 5 animals per group
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Details on inhalation exposure:
- 150 x 7 hours at 0 and 12 mg/m3
14 x 7 hours at 22 mg/m3
5 x 7 hours at 46 mg/m3 - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- max. 35 Weeks
- Frequency of treatment:
- 150 x 7 hours at 0 and 12 mg/m3
14 x 7 hours at 22 mg/m3
5 x 7 hours at 46 mg/m3
Doses / concentrationsopen allclose all
- Dose / conc.:
- 12 mg/m³ air
- Dose / conc.:
- 22 mg/m³ air
- Dose / conc.:
- 46 mg/m³ air
- No. of animals per sex per dose:
- 5 per group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 0 mg/m3 (m: 0/10; f: 0/10), 12 mg/m3 (m: 0/5; f: 0/5), 22 mg/m3 (m: 4/5; f: 5/5), 46 mg/m3 (3/5; f: 5/5)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 0 mg/m3 (m: 0/10; f: 0/10), 12 mg/m3 (m: 0/5; f: 0/5), 22 mg/m3 (m: 4/5; f: 5/5), 46 mg/m3 (3/5; f: 5/5)
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- behavioral disorders, convulsions, coma (n) on the dose, concentration of lead in the brain 10 ug / g
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- vacuolar degeneration and necrosis of cells in the CNS, swollen hepatocytes and Kupffer cells, swelling and necrosis of the proximal and distal renal tubulli, edema, hemorrhages, and inflammations of the lung (n / dose)
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 12 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 22 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- An NOEL of greater than 12 mg/m³ air was reported and a LD100 value of 22 mg/m3 quoted
- Executive summary:
Results very similar to those observed with dogs are reported by Davis et al.
An NOEL of greater than 12 mg/m³ air was reported and a LD100 value of 22 mg/m3 quoted
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