Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich

Endpoint summary

Description of key information

Skin sensitisation

Based on available read across data, Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich is not considered to be a skin sensitizer.

Respiratory sensitisation

No data available

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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 study report that follows a protocol similar to OECD Guideline 429.

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 sensitizing.

Executive summary:

This study was done to determine the concentration of hexane that would be expected to cause sensitization 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 sensitization in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The test substance is therefore not sensitizing.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There is no skin sensitisation data available for Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich. However, data is available for structural analogue Hexane and presented in the dossier. This data is read across to Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Hexane

A study (Basketter, 2000) was done to determine the concentration of hexane that would be expected to cause sensitization 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 sensitization in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The test substance is therefore not sensitizing.

Another study (Fedorowicz, 2004) stated that the results of previous LLNA tests on various tests substances were used to validate a new QSAR model for predicting the skin sensitization potential of chemicals. The model predicted that hexane is not sensitizing, which is in accordance with previous LLNA studies of hexane which have shown it is not sensitizing.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

There are no reports of respiratory sensitisation from Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich in laboratory animals or humans. However, the read across skin sensitisation studies found no indication of skin sensitisation.  With these observations, it is presumed that Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich will not be a respiratory sensitising agent. 

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich 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).