Registration Dossier

Administrative data

Description of key information

Acetyl salicylic acid is not irritating when applied on rabbit skin or eye, did not indicate any irritating final score.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Flemish Giant
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: TS 70% in 30% NaHCO3
Controls:
not required
Duration of treatment / exposure:
4 hours
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acetyl salicylic acid is not irritanty on rabbit skin, while the Na
Executive summary:

Acetyl salicyl acid was not irrtant for rabbit skin in ancted according to B4 EU method.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Flemish Giant
Vehicle:
other: 30% NaHCO3
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acetyl salicylic acid (ASA) is not irritating to the rabbit eye
Executive summary:

ASA tested according to GL 405 is not irritant to the rabbit eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

ASA being not irritating for skin and eyes is also considered not irritating for respiratory tract.


Justification for selection of skin irritation / corrosion endpoint:
key study according to OECD 404

Justification for selection of eye irritation endpoint:
key study according to OECD 405

Justification for classification or non-classification

Results were negative.