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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
other: expert assessment
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexachlorocyclopentadiene
EC Number:
201-029-3
EC Name:
Hexachlorocyclopentadiene
Cas Number:
77-47-4
Molecular formula:
C5Cl6
IUPAC Name:
hexachlorocyclopentadiene

Results and discussion

In vivo (non-LLNA)

Results
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.

Applicant's summary and conclusion

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%.