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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The summary of the study available is well described. No information on the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
intraperitoneal toxicity, Trevan method.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-ethoxy-4-hydroxybenzaldehyde
EC Number:
204-464-7
EC Name:
3-ethoxy-4-hydroxybenzaldehyde
Cas Number:
121-32-4
Molecular formula:
C9H10O3
IUPAC Name:
3-ethoxy-4-hydroxybenzaldehyde
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 230.9 to 277.3 g for males and 200.1 to 213 g for females.
- Fasting period before study: an overnight
- Housing: individually in elevated wire-mesh cages
- Diet (e.g. ad libitum): Commercial rodent ration, ad libidum
- Water (e.g. ad libitum): tap water, ad libitum.
- Acclimation period: 1 week before the start of the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22.2°C
- Humidity (%): 42-79%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h


IN-LIFE DATES: no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: corn oil
Doses:
0; 541; 730; 1000; 1360; 1850 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: All of the animals were observed for signs of toxic and pharmacologic effects at 1, 3, and 6 hours postdose, and once daily thereafter for fourteen consecutive days.
Weight: Individual body weights were recorded immediately prior to treatment, on Day 14, or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathology.
- Mortality/moribundity was recorded twice daily.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 185 mg/kg bw
Based on:
test mat.
95% CL:
> 1 061 - < 1 310
Remarks on result:
other: Calculated LD50 males: 1212 mg/kg (95%CL: 1003-1464 mg/kg bw) Calculated LD50 females: 1131 mg/kg (95%CL: 939- 361 mg/kg bw)
Mortality:
- 541 mg/kg: clinical signs, a variety of commonly noted clinical signs was observed in groups 1-4 with severity increasing with dose.
- 730 mg/kg: clinical signs, lethal, 1 female died on day 12 after dosing.
- 1000 mg/kg: clinical signs
- 1360 mg/kg: clinical signs, lethal, micropathology in organs other than list, 5 females and 3 males died at 1 hour to 9 days following dosing.
- 1850 mg/kg: lethal, five females and four males died one hour after dosing. 1 male died 3 hours after dosing.
Other findings:
Observations frequently noted in some or all of the rats surviving to termination involved the abdominal cavity (abnormal contents), white chunky
material adhered to all organs), involved the lung, liver, kidneys, pancreas, and adrenals (discolored); and the stomach, intestines and abdominal
cavity (abnormal contents).

Applicant's summary and conclusion