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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
other: 1984 EPA Assessment Guideline 40 CFR Part 158
Qualifier:
equivalent or similar to guideline
Guideline:
other: EPA Health Effects Test Guideline 40 CFR Part 798
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaral
EC Number:
203-856-5
EC Name:
Glutaral
Cas Number:
111-30-8
Molecular formula:
C5H8O2
IUPAC Name:
glutaraldehyde
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc. (Indianopolis)
- Age at study initiation: 7 to 9 weeks
- Weight at study initiation: 166 - 267 gram
- Fasting period before study: overnight (approximately 18 hours)
- Housing: Up to 5 per cage (seperated by sex), with wire floors under which animal cage board was placed.
- Diet: Agway RMH3000 certified rodent Pellets. Ad libitum
- Water: Municipal. Ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 21.1 °C
- Humidity (%): 47 - 61%
- Photoperiod (hrs dark / hrs light):12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSE VOLUME APPLIED: The dose volume was adjusted according to bodyweight to give 1 mL of dose per 100 grams of rat bodyweight
Doses:
Male rats: 100, 200, 400 mg/kg bw
Female rats: 100, 141, 200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Dosed rats were observed frequently for signs of toxicity on the first day day of the test and twice a day thereafter.
- Weights were recorded on the day of dosing and at 7 and 14 days after dosing and at death.
- After 14 days, all survivors were sacrificed. Necropsies were performed on all animal that died or that were sacrificed.
Statistics:
LD50 values were calculated by the Moving Average Methtod.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
246 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
154 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 77 mg/kg bw for pure glutaraldehyde
Sex:
male/female
Dose descriptor:
LD50
Effect level:
200 mg/kg bw
Based on:
test mat.
Mortality:
Males:
- 400 mg/kg bw: All animals died within 1 day
- 200 mg/kg bw: One rat died within 2 days. No further mortality occurred.
- 100 mg/kg bw: No mortality occurred.

Females:
- 200 mg/kg bw: Two rats died within 1 day and another Two within 2 days. One rat survived.
- 141 mg/kg bw: Two rats died within 1 day. No further mortality occurred.
- 100 mg/kg bw: No mortality occurred.
Clinical signs:
Sluggishness, lacrimation, piloerection, diarrhea, trace amount of blood in the urine of two rats, a red crust on the perinasal fur and a brown stain on the perineal fur (of 1 rat). Surviving rats recovered within 4 to 5 days.
Body weight:
Surviving animals showed body weight gain over the 14-day post-dose observation period.
Gross pathology:
Necropsy of the rats that died revealed red lunges, red to dark maroon stomachs (some hemorrhaged, 1 filled with red liquid), discolored intestines (yellow, red, brown or black), dark red kidneys (in 2 rats) and a small amount of blood in the urine of 1 rat. Gross pathologic evaluation of survivors revealed no remarkable gross lesions.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Acute oral toxicity (rat, female): LD50 = 77 mg/kg bw (pure glutaraldehyde)