Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
other: case report
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: case report, publication does not give sufficient details

Data source

Reference
Reference Type:
publication
Title:
Toxicity of butylated hydroxytoluene
Author:
Shlian, D., M.; et al.
Year:
1986
Bibliographic source:
The New England Journal of Medicine, vol. 314, 648-649

Materials and methods

Study type:
clinical case study
Endpoint addressed:
acute toxicity: oral
Principles of method if other than guideline:
other: case study
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Subjects:
22-year old white woman
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
estimated

Results and discussion

Clinical signs:
case report

Any other information on results incl. tables

Case of gastritis caused by ingestion of BHT; a 22 -year old white woman ingested 4 g BHT on an empty stomach. Later that evening, she experienced severe epigastric cramping, generalized weakness, nausea and vomiting, followed by dizziness, confusion and a brief loss of consicousness. She was admitted in a dehydrated condition with epigastric burning pain. On admission, the patient's blood pressure was 110/70 mm Hg, with moderate orthostatic changes. The stool guaiac test was negative. She was afebrile, white-cell count of 7400, a normal differential cell count and a hematocrit of 35.8. The results of liver function test, electrolyte measurement, electrocardiography, and electroencephalography were within normal limits. Treatment included hydration, prochlorperazine, and antacids; the symptoms were resolved within a few days.

Applicant's summary and conclusion