Cyclopentadecanone

Endpoint summary

Description of key information

Cyclopentadecanone is not acutely toxic by oral and dermal route.

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

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study predating GLP and modern guidelines, limited documentation, but sufficient to derive LD50 value

Principles of method if other than guideline:

Cyclopentadecanone was administered at the limit dose of 5000 mg/kg bw to 10 rats. Animals were observed for 14 days for mortality and clinical signs.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 75-20

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10/dose (sex unspecified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

Not applied.

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities over the 14 days observation period.

Clinical signs:

No clinical signs were noted.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, LD50 of cyclopentadecanone is > 5000 mg/kg bw.

Executive summary:

In a study predating GLP and modern guidelines, cyclopentadecanone has been administered orally to a group of 10 rats of unspecified sex and strain at a limit dose of 5000 mg/kg bw. Animals were observed for 14 days for mortality and clinical signs. There were no deaths, and no clinical signs were noted. Based on the results of the study, the LD50 of cyclopentadecanone exceeds 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

2 (limited reporting, but the study is performed by a well-known testing lab and is considered reliable).

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

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study predating GLP and modern guidelines, limited reporting, but sufficient to derive LD50.

Principles of method if other than guideline:

Cyclopentadecanone was administered dermally at the limit dose of 5000 mg/kg bw to 10 rabbits. Animals were observed for 14 days for mortality and clinical signs.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 75-20

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10/dose (sex unspecified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

Not applied.

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One rabbit out of 10 died on day 6 post-application.

Clinical signs:

Slight or moderate redness was observed in 2 and 2 rabbits out of 10, respectively. Slight edema was noted in 3 out of 10 animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, acute dermal LD50 of cyclopentadecanone is > 5000 mg/kg bw.

Executive summary:

In the study predating GLP and OECD guidelines, cyclopentadecanone of unspecified purity was administered to 10 rabbits of unspecified sex and strain via dermal route. Animals were observed for 14 days for mortality and clinical signs. There was one death at day 6. Clinical signs were limited to slight or moderate erythema in 4 out of 10, and slight edema in 3 out of 10 rabbits. Based on the results of the study, acute dermal LD50 of cyclopentadecanone exceeds 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

2 (limited reporting, but the study is performed by a well-known testing lab and is considered reliable).

Additional information

In a study predating GLP and modern guidelines, cyclopentadecanone has been administered orally or dermally to a group of 10 rats of unspecified sex and strain at a limit dose of 5000 mg/kg bw. Animals were observed for 14 days for mortality and clinical signs. There were no deaths, and no clinical signs were noted. Based on the results of the study, the acute oral and acute dermal LD50 values of cyclopentadecanone both exceed 5000 mg/kg bw.

Justification for classification or non-classification

Based on the LD50 values for acute oral and acute dermal toxicity > 5000 mg/kg bw, classification for acute toxicity is not warranted for cyclopentadecanone in accordance with Regulation (EC) 1272/2008.