Registration Dossier

Administrative data

Description of key information

Since alkyl anhydrides are usually skin corrosives and eye irritants due to the properties of the anhydridic group, the test item is considered to be classified as skin corrosive categorie 1 and eye irritant categorie 1 based on GHS criteria.

Hexadecanoic acid was found not classified as skin or eye corrosive based on GHS criteria resulting from available data.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Guideline:
other: information not available
Principles of method if other than guideline:
Standard Schwartz-Peck procedure
GLP compliance:
not specified
Remarks:
information not available
Species:
other: human
Type of coverage:
other: closed and open patches
Vehicle:
not specified
Amount / concentration applied:
formulation of 2.2% palmitic acid
Duration of treatment / exposure:
Application to the skin 10-14 days apart in the standard Schwartz-Peck procedure
Number of animals:
101 human subjects
Details on study design:
Two 24-hr closed and open patches are applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure
Irritation parameter:
other: information not available
Remarks on result:
no indication of irritation
Remarks:
3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
Interpretation of results:
GHS criteria not met
Conclusions:
There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Since the test item is a reaction mass of hexadecanoic anhydride and hexadecanoic acid, hexadecanoic acid was used for the read-across.
Reason / purpose:
read-across source
Guideline:
other: information not available
Principles of method if other than guideline:
Standard Schwartz-Peck procedure
GLP compliance:
not specified
Remarks:
information not available
Species:
other: human
Type of coverage:
other: closed and open patches
Vehicle:
not specified
Amount / concentration applied:
formulation of 2.2% palmitic acid
Duration of treatment / exposure:
Application to the skin 10-14 days apart in the standard Schwartz-Peck procedure
Number of animals:
101 human subjects
Details on study design:
Two 24-hr closed and open patches are applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure
Irritation parameter:
other: information not available
Remarks on result:
no indication of irritation
Remarks:
3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
Interpretation of results:
GHS criteria not met
Conclusions:
There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Guideline:
other: information not available
GLP compliance:
not specified
Species:
rabbit
Details on test animals and environmental conditions:
Albino rabbits
Type of coverage:
not specified
Amount / concentration applied:
Formulations of 2.2-74% palmitic acid
Duration of treatment / exposure:
2-24 hr
Irritation parameter:
other: information not available
Remarks on result:
probability of weak irritation
Remarks:
Minimal erythema and no edema
Interpretation of results:
GHS criteria not met
Conclusions:
Administration of product formulations containing 2.2-74% palmitic acid produced minimal erythema and no edema 2-24 hr after application to the skin of albino rabbits
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Since the test item is a reaction mass of hexadecanoic anhydride and hexadecanoic acid, hexadecanoic acid was used for the read-across.
Reason / purpose:
read-across source
Guideline:
other: information not available
GLP compliance:
not specified
Species:
rabbit
Details on test animals and environmental conditions:
Albino rabbits
Type of coverage:
not specified
Amount / concentration applied:
Formulations of 2.2-74% palmitic acid
Duration of treatment / exposure:
2-24 hr
Irritation parameter:
other: information not available
Remarks on result:
probability of weak irritation
Remarks:
Minimal erythema and no edema
Interpretation of results:
GHS criteria not met
Conclusions:
Administration of product formulations containing 2.2-74% palmitic acid produced minimal erythema and no edema 2-24 hr after application to the skin of albino rabbits

Additional information

Justification for classification or non-classification