Glutaral

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:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: 1984 EPA Assessment Guideline 40 CFR Part 158

Test guideline 2

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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

246 mg/kg bw

Based on:

test mat.

Effect levels 2

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

Effect levels 3

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)