Acute inhalation studies with irritant aerosols: Technical issues and relevance for risk characterization

Archives of Toxicology

Volumn 78, Issue 5, 2004, Pages 243-251

  Pauluhn, Jürgen ^a  

^a BAYER PHARMA AG   (Germany)

Author keywords

Aerosols; Classification and labeling; Diisocyanate aerosols; HMDI; Inhalability; Inhalation testing; Lung edema; Lung irritants; MDI; NDI; Pesticide dusts; Respirability; TRIDI

Indexed keywords

1,5 NAPHTHALENEDIISOCYANATE; 2,4 TRIISOPROPYLBENZENE DIISOCYANATE; DICYCLOHEXYLMETHANE 4,4' DIISOCYANATE; DIPHENYLMETHANE 4,4' DIISOCYANATE; FUNGICIDE; ISOCYANIC ACID DERIVATIVE; UNCLASSIFIED DRUG;

AEROSOL; AIRWAY; ANIMAL EXPERIMENT; ANIMAL MODEL; CONCENTRATION RESPONSE; CONTROLLED STUDY; FEMALE; INHALATION; LETHALITY; LUNG EDEMA; LUNG LAVAGE; MALE; MORTALITY; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; RAT; RESPIRATORY SYSTEM; REVIEW; RISK ASSESSMENT; TOXICITY TESTING;

ACUTE TOXICITY TESTS; ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; CYANATES; IRRITANTS; ISOCYANATES; LETHAL DOSE 50; NAPHTHALENES; POLYURETHANES; RATS; RATS, WISTAR; RETROSPECTIVE STUDIES; RISK ASSESSMENT;

EID: 2942527519     PISSN: 03405761     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00204-003-0516-1     Document Type: Review

References (22)

1. AEGL (1999) Draft - Standing Operating Procedures of the National Advisory Committee on Acute Exposure Guideline Levels for Hazardous Substances. EPA, Washington DC, April 30 1999
2. Appelman LM, deJong AWJ (1982). Acute inhalation Toxicity Study of Polymeric MDI in Rats. TNO Report no. V82.050/212478 (unpublished).
3. Bernard BK, Gordon EB (2000) An evaluation of the common mechanism approach to the food quality protection act: captan and for related fungicides, a practical example. Int J Toxicol 19:43-61
4. DOT (US Department of Transportation) (1985) 49 CFR Parts 172 and 173. Packing and Placarding Requirements for Liquids Toxic by Inhalation - Final Rule. Federal Register Vol 50, No. 1995, Tuesday, October 8, 1985
5. DOT (US Department of Transportation) (1994). 49 CFR §173.133 Class 6, Division 6.1. Packing and Placarding Requirements for Liquids Toxic by Inhalation - Final Rule. Federal Register, October 1, 1994
6. Dunlap KL, Sandridge RL, Keller J (1976) Determination of isocyanates in working atmosphere by high performance liquid chromatography. Anal Chem 48:497-499
7. EEC (2001) European Commission, Health & Consumer Protection Directorate-General, Draft Document on Guidance for the setting of an acceptable operator exposure level (AOEL). Document 7531/VI/95 revision 5, dated 3 January 2001
8. European Commission (1992) Directive 92/69/EC Official Journal of the European Community - Legal Specifications L 383 A, 35, December 29, 1992. B.2. Acute Toxicity - Inhalation, p 121
9. European Commission (1994) Directive 94/79/EC of 21 December 1994 amending of Council directive 91/414/EEC concerning the placing of plant protection products on the market. Official Journal of the European Communities - Legal Specifications L354, 16
10. Holzhütter HG, Genschow E, Diener W, Schlede E (2003) Dermal and inhalation acute toxic class methods: test procedures and biometric evaluations for the Globally Harmonized Classification System. Arch Toxicol 77:243-254
11. Kilgour JD, Rattray NJ, Foster J, Soames A, Hext PM (2002) Pulmonary responses and recovery following single and repeated inhalation exposure of rats to polymeric methylene diphenyl diisocyanate aerosols. J Appl Toxicol 22:371-385
12. NFPA (US National Fire Prevention Agency) (1996) NFPA 704: Standard System for the Identification of the Hazards of Materials for Emergency Response, Ed. 1996. www.or-cbs.msu.edu/chemical/nfpa/nfpa.html
13. OECD (Organization for Economic Cooperation and Development) (1981) Guideline for Testing of Chemicals No. 403. Acute Inhalation Toxicity. Adopted 12 May 1981. OECD, Paris
14. Pauluhn J (1994) Validation of an improved nose-only exposure system for rodents. J Appl Toxicol 14:55-62
15. Pauluhn J (2000a) Acute inhalation toxicity of polymeric diphenylmethane-4,4′-diisocyanate (MDI) in rats: time course of changes in bronchoalveolar lavage. Arch Toxicol 74:257-269
16. Pauluhn J (2000b) Inhalation toxicity of 1,6-hexamethylene diisocyanate-homopolymer (HDI-IC) aerosol: results of single inhalation exposure studies. Toxicol Sci. 58:173-181
17. Pauluhn J (2002) Short-term inhalation toxicity of polyisocyanate aerosols in rats: comparative assessment of irritant-threshold concentrations by bronchoalveolar lavage. Inhal Toxicol 14:287-301
18. Reuzel PGJ, Kuper CF, Feron VJ, Appelman LM, Löser E (1994) Acute, subacute, and subchronic inhalation toxicity studies of respirable polymeric methylene diphenyl diisocyanate (polymeric MDI) aerosol in rats. Fundam Appl Toxicol 22:186-194
19. 50) and its error with small computer. J Toxicol Environ Health 3:797-809
20. SOT (Society of Toxicology) (1992) Commentary. Recommendations for the conduct of acute inhalation limit tests, prepared by the technical committee of the inhalation specialty section of SOT. Fundam Appl Toxicol 18:321-327
21. US EPA (1998) Health effects test guidelines 870.1300 - acute inhalation toxicity. OPPTS 870.1300. United States Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, EPA 712C-98-193, August 1998
22. US EPA (2002) Guidance: waiver criteria for multiple-exposure inhalation toxicity studies. United States Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Washington DC, August 15 2002