Dodecan-5-olide

Endpoint summary

Description of key information

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Maximization test

Principles of method if other than guideline:

A maximization test was performed to determine the sensitization potential of the test chemical

GLP compliance:

not specified

Type of study:

other: Maximization test

Justification for non-LLNA method:

Currently no LLNA study is available for assessment.

Species:

other: humans

Strain:

not specified

Sex:

not specified

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

12% in petrolatum

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

12% in petrolatum

Adequacy of challenge:

not specified

No. of animals per dose:

30

Details on study design:

no data available

Challenge controls:

no data available

Positive control substance(s):

not specified

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

12% in petrolatum

No. with + reactions:

0

Total no. in group:

30

Clinical observations:

No dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.

Executive summary:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 12% in petrolatum was applied to the skin of 30 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

 Skin Sensitization

Various studies have been summarized to evaluate the dermal sensitization potential of the test chemical in living organisms. These include in vivo experimental studies on guinea pigs, humans along with the estimated data for the test chemical.

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 12% in petrolatum was applied to the skin of 30 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers.

Hence, the test chemical was considered to be not sensitizing to skin.

This is supported by another maximization test performed on guinea pigs to determine the allergic potential of the test chemical.

Intradermal injections of 0.1 ml of 0.1% suspension (w/v) of the test chemical in a mixture of containing 1 volume of propylene glycol and 29 volume of saline were given in the induction phase to 10 male guinea pigs. After a suitable rest period, ten test guinea pigs received and challenged with 0.1% solution of the test chemical.

Ten test guinea pigs received and challenged with 0.1% solution of the positive control [DNCB]. In addition, ten cage control guinea pigs [ Five receiving challenge dose of the test compound without prior sensitizing dose, Five receiving challenge dose of DNCB without prior sensitizing doses] were also used. Positive control [DNCB] produced a marked sensitization reaction in 10/10 guinea pigs. Cage control guinea pigs showed no greater reaction to the test chemical and DNCB than were seen in original test groups.

Challenge doses of the test chemical(last intradermal injection) did not produce a sensitization effect.

The test chemical did not produce a sensitization reaction under these test conditions and is not expected to cause sensitization reaction to humans.

Hence, the test chemical was considered to be sensitizing to skin.

Skin sensitization effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.

The estimated and experimental studies are in mutual agreement with each other indicating a strong possibility that the test chemical was indeed not sensitizing

to skin. Hence, the test chemical can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The estimated and experimental studies are in mutual agreement with each other indicating a strong possibility that the test chemical was indeed not sensitizing to skin. Hence, the test chemical can be considered to be not sensitizing to skin.