[No public or meaningful name is available]

Endpoint summary

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

Reference

Reference 1

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

Reference 2

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 for cross-reference:

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

Reference 3

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 or test system 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

Reference 4

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 for cross-reference:

read-across source

Guideline:

other: information not available

GLP compliance:

not specified

Species:

rabbit

Details on test animals or test system 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