3-diethylaminophenol

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

The Oral Toxicity of Resorcinol During Pregnancy: A Case Report

Author:

Bulent Duran, Sinan Gursoy, Meral Cetin, Nihal Demirkoprulu, Yeltekin Demirel, and Bilge Gurelik

Year:

2004

Bibliographic source:

Journal of Toxicology CLINICAL TOXICOLOGY Vol. 42, No. 5, pp. 663–666, 2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The present work aimed to report a resorcinol poisoning case in which resorcinol was taken accidentally by a woman at 30 weeks of
pregnancy.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Resorcinol

Cas Number:

Resorcinol

Molecular formula:

C6H6O2

IUPAC Name:

Resorcinol

Constituent 2

Reference substance name:

1,3-Benzenediol

Cas Number:

108-46-3

Molecular formula:

C6H6O2

IUPAC Name:

1,3-Benzenediol

Constituent 3

Reference substance name:

Resorcinol

EC Number:

203-585-2

EC Name:

Resorcinol

Cas Number:

108-46-3

Molecular formula:

C6H6O2

IUPAC Name:

1,3 benzenediol

Details on test material:

- Name of test material (as cited in study report):resorcinol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

other: Human

Sex:

female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on mating procedure:

30 week pregnant female

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

24 hrs

Frequency of treatment:

once

Doses / concentrations

Remarks:

Doses / Concentrations:
50g (50000 mg)
Basis:
nominal conc.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

effects observed, treatment-related

Body weight and weight changes:

not examined

Food consumption and compound intake (if feeding study):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Histopathological findings: non-neoplastic:

not examined

Other effects:

not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not examined

Reproductive function: sperm measures:

not examined

Reproductive performance:

not examined

Details on results (P0)

Within minutes following resorcinol ingestion, the patient described sore throat, tachycardia, shortness of breath, and shivering.

The mother’s Glasgow Coma Score was 7–8 on the second day of hospitalization. While she had some agitations, she had no seizures. She was extubated on day 4. She was orientated, cooperative and her Glasgow Coma Score was 13–14, whereas it became 15 on day 5. Her urine color was green when first accepted to the ICU (9 h after resorcinol ingestion) whereas it was normal color on day 3. Her CVP was 14–16 mmHg, which had been controlled within normal limits successfully. During the first 3 days, she had hypothermia (35.2C) which became normal in correlation with the urine color. After the first 3 days, the urine samples were positive for protein, glucose, acetone, bilirubin, and urobilinogen. The hemoglobin level decreased to 9.9 g/dl within 5 days, which was 12.6 g/dl at the beginning. She has leucocytosis (25 000/mm3) and high bilirubin levels (direct-reacting bilirubin: 4.5, total bilirubin: 8 as highest levels). Bilirubin levels first increased indirectly, which was followed by direct bilirubin on day 2. Also, fibrinogen, fibrin degradation products, CRP, sedimentation and amylase levels increased on day 2. The activity of the liver enzymes increased after 5 days of hospitalization (alanine transferase: 148, aspartate transferase: 86, lactate dehydrogenase: 1789 as the highest values). An esophageal barium X-ray revealed an open passage on day 7, thereafter the patient were fed orally. The patient received only supportive treatment other than a specific antidote at the ICU.

Effect levels (P0)

Dose descriptor:

LOAEL

Effect level:

50 000 other: mg

Based on:

test mat.

Sex:

female

Basis for effect level:

other: see 'Remark'

Results: F1 generation

General toxicity (F1)

Clinical signs:

effects observed, treatment-related

Mortality / viability:

mortality observed, treatment-related

Body weight and weight changes:

no effects observed

Sexual maturation:

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings:

not examined

Details on results (F1)

The newborn was apneic, cyanotic, and bradycardic with Apgar scores of 4–5 at 1 and 5 min. The newborn was intubated and transferred to the neonatal ICU for mechanical ventilation. It had distinctive substernal, suprasternal, and intercostal retractions. It was tachypenic (88/min), body temperature was hypothermic (35.1C), blood pressure was 40/ 20 mmHg, and pulse rate was 160/min. The newborn’s urine color was normal whereas its blood samples revealed hypoxia and metabolic acidosis (pH: 6.95, PO2: 26 mmHg, PCO2: 24 mmHg). The hemoglobin level of the newborn was 17 g/dl. The X-ray graph of the lung demonstrated diffuse pulmonary atelectasis and increased opacity of the lung fields. The newborn was considered dead 24 h after delivery in spite of all supportive treatment given.

Results: F2 generation

Effect levels (F2)

Remarks on result:

not measured/tested

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The maternal LOAEL of resorcinol in 30 weeks pregnant human female was observed at dose concentration of 50000 mg

Executive summary:

A 30 weeks pregnant female has accidently taken ingested 50g (50000 mg) resorcinol and has suffered resorcinol piosioning. The major clinical findings were unconsciousness, drowsiness, and respiratory failure that required mechanical ventilation along with tonic-clonic seizures and hypothermia. In addition, the laboratory findings were leucocytosis, high bilirubin levels, severe metabolic acidosis, and green-colored urine. The fetus was considered dead 24 h after delivery; however, mother’s prognosis was well with

supportive management.