O-acetylsalicylic acid

Endpoint summary

Description of key information

Rabbit LD50 > 7940 mg/kg

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:

other: BPL not indicated

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:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

1 week acclimation of 5 weeks animals

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

administration 16 hours afetr feed deprivation

Doses:

6 doses:

No. of animals per sex per dose:

10

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 850 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 600

Based on:

test mat.

Also tested on male Sprague Dawley with arabic gum: LD50 = 1900 (1660 -2200)

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In a well conducted LD50 study with wistar rats male(10) per dose / 6 doses and female (10), there is a slight difference between sexes (m1850 /f1600) leading by statistical analysis to a mean LD50 of 1725 mg/kg

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 725 mg/kg bw

Quality of whole database:

weigh of evidence

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: Summary on IUCLID (HEDSET) in existing Chemicals

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

Dutch

Sex:

not specified

Type of coverage:

semiocclusive

Duration of exposure:

24 hours

Control animals:

not required

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 7 940

Based on:

test mat.

Certainly combined with the dermal corrosion irritation assay

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

ASA is not toxic by dermal application on rabbit. This confirm the low dermal penetration.

Executive summary:

With an LD50 > 7940 mg/kg in rabbit, ASA is not classified and did not justify any further study with rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

The acute oral toxicty is limited (1725 mk/kg) with an absorption of 80% and the dermal one (>7940 mg/kg) reflects the low dermal penetration of ASA (<2%).

Justification for selection of acute toxicity – oral endpoint
Between the older value of 1500 and the more recent one of 1992 mg/kg, which do not indicate the sex used, this one give a LD50 by sex and a mean of 1725 mg/kg according to statistics.

Justification for selection of acute toxicity – inhalation endpoint
ASA is a crystalline powder of high MMAD (>500um) and only some % are below the human inhalable fraction. For rat it will need an MMAD of 2 um.

Justification for classification or non-classification

ASA is classified for acute oral toxicity as harmful.