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Administrative data

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:
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 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:
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.