Glutaric anhydride

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study appears to be well conducted. No evidence that GLP was followed, but likely conducted in the spirit of GLP. Study used an appropriate number fo animals to assess the endpoint.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Males - 500mg, 1000mg, 2000mg, 8000mg
Females - 250 m, 500mg, 1000mg

No. of animals per sex per dose:

Males
500 mg = 5
1000 mg = 5
2000 mg = 5
8000 mg = 2

Females
250 mg = 5
500 mg = 5
1000 mg = 5

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

1 410 mg/kg bw

95% CL:

> 800 - < 2 490

Sex:

female

Dose descriptor:

LD50

Effect level:

540 mg/kg bw

95% CL:

> 360 - < 790

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Female rats appeared to be more sensitive to the effects of the test material. Based on the LD50 value reported for the female rats, the substance meets the criteria for classification as Harmful in the EU.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Standard Acute toxicity methodolgy followed - Rats dosed with test substance and then observed for up to 14 days. However rats were dosed with both test material solution and then an equal volume of water to assess the effect of dilution on the acute toxicity.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Males:
16 ml/kg = 4 g/kg bw
8 ml/kg = 2 g/kg
4 ml/kg = 1 g/kg
2 ml/kg = 0.5 g/kg
1ml/kg = 0.25 g/kg

Females:
4 ml/kg = 1 g/kg
2 ml/kg = 0.5 g/kg
1 ml/kg = 0.25 g/kg

No. of animals per sex per dose:

Males:
2 animals per dose for the 0.25g/kg dose group, 5 animals per dose for the other dose groups total = 22

Females:
5 animals per dose group. Total = 15

Control animals:

no

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

5.66 mL/kg bw

95% CL:

> 3.35 - < 9.55

Remarks on result:

other: as 25% w/v in corn oil

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 420 mg/kg bw

95% CL:

> 838 - 2 388

Remarks on result:

other: as test substance

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 620 mL/kg bw

95% CL:

> 1 180 - < 2 240

Remarks on result:

other: as 25% w/v in corn oil

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

400 mg/kg bw

95% CL:

> 295 - < 560

Remarks on result:

other: as test substance

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute toxicity of the test substance does not appear to be moderated by the subsequent dosing of an equal volume of water.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed