Ethyl formate

Endpoint summary

Description of key information

Skin Sensitization:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. 4% test chemical in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

4% test chemical in petrolatum did not induce any sensitization reactions on the skin of 23 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)

Remarks:

in vivo

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: Human maximization test

Principles of method if other than guideline:

Human maximization test was carried out to determine the allergenic potential of the test chemical

GLP compliance:

no

Type of study:

other: Human maximization test

Justification for non-LLNA method:

not specified

Species:

other: humans

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data available

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

4% in petrolatum

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

4% in petrolatum

Adequacy of challenge:

not specified

No. of animals per dose:

23 human volunteers

Details on study design:

No data available

Challenge controls:

No data available

Positive control substance(s):

not specified

Positive control results:

No data available

Reading:

1st reading

Group:

test chemical

Dose level:

4% in petrolatum

No. with + reactions:

0

Total no. in group:

23

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 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 4% in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 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:

In various studies, the test chemical has been investigated for potential to cause dermal sensitization to a greater or lesser extent. The studies are based on in vivo experiments in humans for test chemicals. The results are summarized as follows:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 4% in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.

Hence, the test chemical was considered to be not 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.

These results are further supported by a human maximization test performed to evaluate the sensitization potential of the test chemical. The test chemical 3% in petrolatum was applied to the skin of 23 human volunteers and observed for dermal reactions (duration of exposure and observation period not specified). The test chemical 3% in petrolatum when tested for skin sensitization on 23 human volunteers showed no skin reaction. Hence, it can be considered as not skin sensitizer for human skin.

The above results are also supported by the results of a human maximization test performed to determine the sensitization potential of the test chemical. The test chemical 12% in petrolatum was applied to the skin of 25 human volunteers and observed for effects (duration of exposure, observation period). The test chemical 12% in petrolatum failed to induce any dermal reactions on the skin of human volunteers.

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

Based on the results obtained for the test chemicals and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Available data for the test chemical indicates that it is not likely to induce any dermal reactions.

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