Hexachlorocyclopentadiene

Endpoint summary

Description of key information

A Harmonised Classification as R43 was proposed in the EU Risk Assessment Report (2007) for Hexachlorocyclopentadiene with specific concentration limits of 0.001% ≤ C < 0.1%. This proposal was based on available data on the potential of the substance to induce skin sensitisation and can be translated as a classification as Skin Sens. 1; H317 according to Regulation (EC) N° 1272/2008.

While it was not possible to access the reports mentioned in the EU Risk Assessment Report (2007), these data were considered as reliable for the purpose of this risk assessment. They are therefore considered as sufficient in order to fulfil the requirements of Annex VII of REACH regarding the skin sensitisation.

From the results of the study performed by Price (1982) according to a method similar to the OECD Testing Guideline 406, it can be concluded that the substance is sensitising to the skin and should be classified as Skin Sens. 1; H317 according to Regulation (EC) N° 1272/2008. This classification is supported by the outcome of the skin sensitisation study performed by the International Research and Development Corporation (1978).

In addition, Price (1982) determined that a concentration of 0.05% (w/v) of Hexachlorocyclopentadiene in corn oil was sufficient to induce the skin sensitisation. It is therefore proposed specific concentration limits of 0.001% ≤ C < 0.1%.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

other: An assessment was performed based on the proposed Harmonised Classification and data on the in vivo skin sensitisation of the substance.

Adequacy of study:

weight of evidence

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed based on the proposed Harmonised Classification and data on the in vivo skin sensitisation of the substance.

Qualifier:

no guideline followed

Principles of method if other than guideline:

An assessment was performed based on the proposed Harmonised Classification and data on the in vivo skin sensitisation of the substance.

GLP compliance:

no

Type of study:

other: An assessment was performed based on the proposed Harmonised Classification and data on the in vivo skin sensitisation of the substance.

Justification for non-LLNA method:

Data was available on the in vivo skin sensitisation of the substance resulting from non-LLNA testing.

Key result

Remarks on result:

other: An assessment was performed based on the proposed Harmonised Classification and data on the in vivo skin sensitisation of the substance.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Hexachlorocyclopentadiene is sensitising to the skin and should be classified as Skin Sens. 1; H317 (May cause an allergic skin reaction) with specific concentration limits of 0.001% ≤ C < 0.1%. It is not considered relevant to further investigate the potential of the substance to induce skin sensitisation.

Executive summary:

A Harmonised Classification as R43 was proposed for Hexachlorocyclopentadiene with specific concentration limits of 0.001% ≤ C < 0.1%. This proposal was based on available data on the potential of the substance to induce skin sensitisation and can be translated as a classification as Skin Sens. 1; H317 (May cause an allergic skin reaction) according to the CLP Regulation

While it was not possible to access the study reports, these data were considered as reliable and sufficient by the Dutch Competent Authority (EU, 2007) in order to fulfil the requirements of Annex VII of REACH regarding the skin sensitisation.

From the results of the study performed by Price (1982) according to a method similar to the OECD Testing Guideline 406, it can be concluded that the substance is sensitising to the skin and should be classified as Skin Sens. 1; H317 (May cause an allergic skin reaction) according to the CLP Regulation. This classification is supported by the outcome of the skin sensitisation study performed by the International Research and Development Corporation (1978).

As a conclusion Hexachlorocyclopentadiene is sensitising to the skin and should be classified as Skin Sens. 1; H317 (May cause an allergic skin reaction). It is not considered relevant to further investigate the potential of the substance to induce skin sensitisation.

In addition, Price (1982) determined that a concentration of 0.05% (w/v) of Hexachlorocyclopentadiene in corn oil was sufficient to induce the skin sensitisation. It is therefore proposed specific concentration limits of 0.001% ≤ C < 0.1%.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Justification for classification or non-classification

A Harmonised Classification as Skin Sens. 1; H317 is currently attributed to Hexachlorocyclopentadiene for skin sensitisation. There is no reliable data available indicating that a more severe classification should apply to the substance for this endpoint.

Price (1982) determined that a concentration of 0.05% (w/v) of Hexachlorocyclopentadiene in corn oil was sufficient to induce the skin sensitisation. It is therefore proposed specific concentration limits of 0.001% ≤ C < 0.1%.