[No public or meaningful name is available]

Endpoint summary

Description of key information

Since hexadecanoic anhydride decomposes to hexadecanoic acid when administered via oral route, only hexadecanoic acid was considered for the assessment of the acute toxicity.

Based on available study results, hexadecanoic acid results not toxic via oral route, therefore also the test item doesn't meet the GHS criteria for the classifcation as oral toxic and is considered not toxic via oral route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

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

Specific details on test material used for the study:

Commercial grade

Species:

rat

Details on test animals or test system and environmental conditions:

Albino rats

Route of administration:

oral: gavage

Doses:

Administration of doses up to 10.0 g/Kg

Key result

Dose descriptor:

other: information not available

Remarks on result:

other: Transient signs of toxicity observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid

Mortality:

Administration of doses up to 10.0 g/Kg Palmitic Acid resulted in no deaths

Clinical signs:

other: Transient signs of toxicity observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid. Signs of toxicity included slight CNS/depression, depressed righting and placement reflexes, oily and unkempt flur, mucoid diarrhea, excessive sali

Gross pathology:

Administration of doses up to 10.0 g/Kg Palmitic Acid resulted in no significant gross lesions at necroscopy

Interpretation of results:

GHS criteria not met

Conclusions:

Administration of doses up to 10.0 g/Kg Palmitic Acid by galvage to albino rats resulted in no deaths and no significant gross lesions at necroscopy. Transient signs of toxicity were observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid. Signs of toxicity included slight CNS/depression, depressed righting and placement reflexes, oily and unkempt flur, mucoid diarrhea, excessive salivation and serosanguineous discharge from the muzzle and eyes.

Reference 2

Endpoint:

acute toxicity: oral

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

Specific details on test material used for the study:

Commercial grade

Species:

rat

Details on test animals or test system and environmental conditions:

Albino rats

Route of administration:

oral: gavage

Doses:

Administration of doses up to 10.0 g/Kg

Key result

Dose descriptor:

other: information not available

Remarks on result:

other: Transient signs of toxicity observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid

Mortality:

Administration of doses up to 10.0 g/Kg Palmitic Acid resulted in no deaths

Clinical signs:

other: Transient signs of toxicity observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid. Signs of toxicity included slight CNS/depression, depressed righting and placement reflexes, oily and unkempt flur, mucoid diarrhea, excessive sali

Gross pathology:

Administration of doses up to 10.0 g/Kg Palmitic Acid resulted in no significant gross lesions at necroscopy

Interpretation of results:

GHS criteria not met

Conclusions:

Administration of doses up to 10.0 g/Kg Palmitic Acid by galvage to albino rats resulted in no deaths and no significant gross lesions at necroscopy. Transient signs of toxicity were observed in rats of the higher dose groups of 4.64 and 10.0 g/Kg Palmitic acid. Signs of toxicity included slight CNS/depression, depressed righting and placement reflexes, oily and unkempt flur, mucoid diarrhea, excessive salivation and serosanguineous discharge from the muzzle and eyes.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Guideline:

other: information not available

GLP compliance:

not specified

Remarks:

Information not available

Species:

rat

Route of administration:

oral: unspecified

Key result

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the test result (LD50 Rat oral >10000 mg/kg), hexadecanoic acid is not considered toxic via oral route.

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

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

Remarks:

Information not available

Species:

rat

Route of administration:

oral: unspecified

Key result

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the test result (LD50 Rat oral >10000 mg/kg), hexadecanoic acid is not considered toxic via oral route.