Glutaric anhydride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glutaric anhydride

EC Number:

203-593-6

EC Name:

Glutaric anhydride

Cas Number:

108-55-4

Molecular formula:

C5H6O3

IUPAC Name:

glutaric anhydride

Test material form:

solid: crystalline

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

Females
2g, 4g, 8g /kg bw
Males
2g, 4g, 5.66g, 8g /kg bw

No. of animals per sex per dose:

Males: 5 per dose for the 4, 5.66 and 8 g/kg bw doses, 2 per dose for the 2 g/kg bw dose

Females: 5 per dose for all doses

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

6 250 mg/kg bw

95% CL:

> 5 340 - < 7 330

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 660 mg/kg bw

95% CL:

3 210 - 9 950

Any other information on results incl. tables

By the percutaneous route, the LD50 for male rabbits was 6.25 g/kg. The LD50 for females was 5.66 g/kg. Local dermal effects included erythema, edema, necrosis, ecchymosis, desquamation, fissuring, ulceration, scabs and alopecia. Sluggishness, unsteady gait and emaciation were among the signs of toxicity observed. Time to death usually ranged from one to 3 days. One female succumbed at 10 days. One affected survivor recovered at 2 days. Gross pathologic findings included salmon-colored to red lungs, lungs of one with tan nodules and adhesions, one dark-red liver with tan areas, one distended abdomen, stomachs with multiple black foci (in 2), one light-red thymus, pale-tan kidneys or pitted kidneys and subcutaneous edema in one.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Whilst the substance appears to be severely irritating under the circumstances of the study, it did not demonstrate significant systemic toxicity and both LD50 values for male and female rabbits were in excess of 5000 mg/kg bw. Therefore the test substance does not meet the critera for classification for acute dermal toxicity.