Hydrocarbons, C6, isoalkanes, <5% n-hexane

Endpoint summary

Description of key information

Skin Sensitisation

Hexane was not a dermal sensitizer in a mouse local lymph node assay (LLNA) (OECD TG 429). Using read-across data from hexane, Hydrocarbons, C6, isoalkanes, <5% n-hexane was determined not to be a skin sensitizer using the mouse local lymph node assay (LLNA) (OECD TG 429).

Respiratory Sensitisation

no data

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

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

Adequacy of study:

key study

Study period:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

not specified

Sex:

not specified

Vehicle:

acetone/olive oil (4:1 v/v)

Statistics:

Results were given in terms of the EC3 value, the concentration of the substance which is expected to cause a 3-fold increase in proliferative activity. EC3 values were determined based on results of previous LLNA tests for the test substance.

Key result

Parameter:

EC3

Test group / Remarks:

Test substance (100%)

Remarks on result:

other: EC3 > 100%

Parameter:

SI

Test group / Remarks:

Test Concentration 1

Remarks on result:

not measured/tested

Remarks:

Results of previous LLNA experiments were used to calculate the EC3 value

Parameter:

SI

Test group / Remarks:

Test Concentration 2

Remarks on result:

not measured/tested

Remarks:

Results of previous LLNA experiments were used to calculate the EC3 value

Parameter:

SI

Test group / Remarks:

Test Concentration 3

Remarks on result:

not measured/tested

Remarks:

Results of previous LLNA experiments were used to calculate the EC3 value

Interpretation of results:

other: Not sensitising

Conclusions:

Concentrations of up to 100% of test substance are not expected to be sensitising.

Executive summary:

This study was done to determine the concentration of hexane that would be expected to cause sensitisation in humans. Results of previous LLNA experiments were used to calculate the EC3 value, the concentration at which the test substance would produce a 3 -fold increase in the proliferative activity of lymph nodes in the LLNA test. The 3 -fold increase is considered a positive response for sensitisation in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The test substance is therefore not sensitising.

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated Data from field(s)
Field "Additional information" (Path: ENDPOINT_SUMMARY.Sensitisation.KeyValueForChemicalSafetyAssessment.SkinSensitisation.EndpointConclusion.AdditionalInformation): Content available as attachment under file "NoMigratedDataForAdditional information_26 May 2023 164434.html"
Field "Additional information" (Path: ENDPOINT_SUMMARY.Sensitisation.KeyValueForChemicalSafetyAssessment.RespiratorySensitisation.EndpointConclusion.AdditionalInformation): Content available as attachment under file "NoMigratedDataForAdditional information_26 May 2023 164434.html"

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated Data from field(s)
Field "Additional information" (Path: ENDPOINT_SUMMARY.Sensitisation.KeyValueForChemicalSafetyAssessment.SkinSensitisation.EndpointConclusion.AdditionalInformation): Content available as attachment under file "NoMigratedDataForAdditional information_26 May 2023 164434.html"
Field "Additional information" (Path: ENDPOINT_SUMMARY.Sensitisation.KeyValueForChemicalSafetyAssessment.RespiratorySensitisation.EndpointConclusion.AdditionalInformation): Content available as attachment under file "NoMigratedDataForAdditional information_26 May 2023 164434.html"

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C6, isoalkanes, <5% n-hexane does not meet the criteria for classification as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).