Diethyl malonate

Endpoint summary

Description of key information

The LD50 oral value determined by the study is 15.8 g/kg. This value is far above the limit for a classification as acute toxic.

It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.

Exposure of humans is unlikely due to the low vapour pressure of the substance. The oral and dermal routes are considered to be the most relevant exposure routes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

other: as described by Smyth et al., Amer. Ind. Hyg. Assoc. J. 23, 95-107

GLP compliance:

not specified

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

age 4 - 5 weeks
weight 90 - 120 g

Route of administration:

other: gastric intubation

No. of animals per sex per dose:

5 per dose

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

15 794 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value determined by the study is 15.8 g/kg. This value is far above the limit for a classification as acute toxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

15 794 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically valid. Adopted according to OECD SIDS (public available peer reviewed source).

Qualifier:

according to guideline

Guideline:

other: According to 24-hour cuff method of Draize et al. 1944

Principles of method if other than guideline:

The LD50 was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino New Zealand rabbits. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days.

GLP compliance:

no

Test type:

standard acute method

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Type of coverage:

occlusive

No. of animals per sex per dose:

4 per dose

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 960 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

16 960 mg/kg bw

Additional information

It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.