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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The No-effect dose of aniline in human subjects and a comparison of aniline toxicity in man and the rat
Author:
Jenkins FP, Robinson JA, Gellatly JB, Salmond GW.
Year:
1972
Bibliographic source:
Food Cosmet Toxicol. 10, 671-679

Materials and methods

Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
study on human volunteers, no guideline followed
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Aniline
EC Number:
200-539-3
EC Name:
Aniline
Cas Number:
62-53-3
Molecular formula:
C6H7N
IUPAC Name:
aniline
Details on test material:
- Name of test material (as cited in study report): aniline
- Analytical purity: no data (redestilled)

Method

Ethical approval:
not specified
Details on study design:
Effects of aniline ingestion on hematotoxicity was examined in 20 human volunteers/17 males and 3 females). Doses of 5, 15 and 25 mg aniline, respectively, were administered on three consecutive days to each of 20 volunteers. Higher doses of aniline, i.e. 35, 45, 55, 65 mg were then administered to 5, 5, 2, 1 of these volunteers, respectively.

Results and discussion

Results:
Following oral administration of aniline to human volunteers a dose dependent increase in the percentage of MetHb was observed. Maximum increase in MetHb was observed after 1 - 4 hours. The no-effect dose in this study was 15 mg/man based on the lack of hematotoxicity (increase in MetHb level, formation of Heinz bodies). Based on the MetHb increase of 3.7% the NOAEL of the study was 35 mg/man.

Any other information on results incl. tables

Blood samples taken 24 hr after each dose of aniline revealed no adverse effect upon packed cell volume, reticulocyte count, bilirubin or urobilinogen, except for a slight increase of serum bilirubin in two males following the administration of 45 and 65 mg aniline. Aniline had no adverse effect on serum proteins, serum enzymes, blood urea or the thymol turbidity test. No Heinz bodies were detected and the examination of blood films and buffy coat preparations revealed no abnormal features. No significant increase in MetHb was observed 1, 2 and 3 h after application of 5 mg and 15 mg aniline. After exposure to 25 mg aniline an increase in MetHb of 2.5% versus 1.2/1.8% in the two lower doses was observed. Exposure to 45 mg aniline lead to an increase in MetHb level of 7% (5 volunteers) and one volunteer who received a dose of 65 mg had a level of 15% Met-Hb. The mean maximum increase in MetHb was observed in less than 4 hours after intake. The no-effect dose of aniline in adult man in this study is 15 mg/man. The NOAEL was determined with 35 mg/man.

Applicant's summary and conclusion