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EC number: 203-856-5 | CAS number: 111-30-8
Acute Toxicity: oral
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:
- 1 992
- 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
- 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
Constituent 1
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:
- other: 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.
- 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)
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