Registration Dossier
Registration Dossier
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EC number: 202-810-1 | CAS number: 100-01-6
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from an authoritative source and the process of obtaining the reprint that shall give legitimate access to the study is on-going.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- A four-week inhalation toxicity study of para- Nitroanaline in the rat
- Author:
- Nair et al.
- Year:
- 1 986
- Bibliographic source:
- Solutia study BD-80-508. A four-week inhalation toxicity study of para- Nitroanaline in the rat; also published as Nair et al. (1986) Fundamen Appl Toxicol 6:618
- Reference Type:
- other: Authoritative data base
- Title:
- GCID: 48
- Author:
- ACToR database
- Year:
- 2 011
- Bibliographic source:
- ACToR (Aggregated Computational Toxicology Resource);Solutia study BD-80-508. A four-week inhalation toxicity study of para- Nitroanaline in the rat; also published as Nair et al. (1986) Fundamen Appl Toxicol 6:618
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- data obtained from Actor database
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-nitroaniline
- EC Number:
- 202-810-1
- EC Name:
- 4-nitroaniline
- Cas Number:
- 100-01-6
- Molecular formula:
- C6H6N2O2
- IUPAC Name:
- 4-nitroaniline
- Details on test material:
- - Name of test material (as cited in study report): 4-nitroaniline
- Substance type: Organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: Aerosol
- Details on inhalation exposure:
- vehicle Aerosol derived by passing air over PNA dissolved in isopropanol and warmed.
- Analytical verification of doses or concentrations:
- not specified
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 32, 80 mg/m3 (analytical)
Basis:
analytical conc.
- No. of animals per sex per dose:
- total no. of animals: 40
- Control animals:
- yes
- Details on study design:
- sub-acute exposure period: 6 hours per day, 5 days per weekcontrol group: yes, concurrent vehicle Aerosol derived by passing air over PNA
dissolved in isopropanol and warmed. Groups of 10 rats/sex/group were housed in stainless steel and glass chamber and exposed under whole
body conditions to one of three levels of test material. A vehicle control group was exposed to isopropanol in a similar fashion and treated similarly for evaluation. Chamber atmospheres and particle size were analytically determined. Dosing occurred 6h/d, 5d/wk for 4 consecutive weeks; animals
were observed daily for clinical signs, weighed weekly, food and water given ad libitum , serum chemistry (BUN, SGPT, SAP, GLU, ALB, T.Protein, Glob.,
Na, K, P, Ca, Cl) and hematology (Hgb, HCT, RBC, Methem., clot time,T/Differ. Leuko, red cell morph) parameters collected on day 0 and 28.
Ophthalmoscopic exams conducted on day 0 and 28. Organ weights (gonads, hrt, kid, lvr, lu, pit, spln, brain) recorded at termination; all animals
necropsied at term; microscopic evaluation of approx. 40 tissues and organs (including gonads) for all high dose and control rats; spleens examined for all lower dose animals. Statistical methods used included: Bartletts test
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 10 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: non-significant elevation in blood methemoglobin,significant increases in mean spleen weight (both sexes), iron deposition and extramedullary hematopoiesis seen in spleens (both sexes)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEC (no observed adversed effect concentration) value observed was 10 mg/m³ air in rat by inhalation exposure in a subacute study conducted with 4-nitroaniline which shows non-significant elevation in blood methemoglobin.
- Executive summary:
The NOAEC (no observed adversed effect concentration) value observed was 10 mg/m³ air in rat by inhalation exposure in a subacute study conducted with 4-nitroaniline which shows non-significant elevation in blood methemoglobin.
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