Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
1.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on other data
Dose descriptor starting point:
other: not applicable
Modified dose descriptor starting point:
other: not applicable
Explanation for the modification of the dose descriptor starting point:
Not applicable
Justification:
See additional information - workers.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Acute toxicity - systemic effects

Benzene is legally classified as cancer Cat 1A in the EU. According to ECHA Guidance Part E: Risk Characterisation, Version 3.0 the substance belongs to the high hazard catergory, no threshold was derived as the substance is only used as intermediate.

Acute toxicity – local effects

The risk management measures in place for carcinogenicity will provide adequate protection against the occurrence of local effects following acute exposure.

Sensitization

No hazard with respect to skin or respiratory sensitization has been identified in animal studies or in humans and, consequently, no DNEL can or will be proposed.

Explanation for the Worker DNEL at 0.6 ppm (1.9 mg/m3) as an 8 hour TWA

The DMEL used in previous versions of the REACH benzene dossier was based on the EU BOELV of 1 ppm which was derived from the position on benzene toxicology presented by SCOEL in SUM 140 (SCOEL, 1991). Our analysis of the body of research that has developed since then, agrees with the conclusion of DECOS (Netherlands) that the evidence on benzene justifies the setting of a DNEL rather than a DMEL (DECOS, 2014). This position is based on the view that benzene is not a direct-acting mutagen, that clastogenic events will be thresholded, and that the key toxicity is haematotoxicity. If haematotoxicity is avoided, then progression to oncological disease would not be expected (LOA 2017).

The use of the EU BOELV as a basis for a DMEL was based on the provision in REACH guidance that allows a DNEL/DMEL to be based on accepted formal workplace limits providing that no data exist that would contradict the basis of the formal workplace limit. (Guidance R8 Appendix 13). Pending the setting of a new EU BOELV value for benzene, LOA believes that the DECOS document and other recent literature provide enough justification to contradict the 1 ppm EU BOELV.  LOA’s interim position is that the haematological data reviewed by the DECOS, as well as more recent research provides justification for a DNEL of 0.6 ppm, three times that proposed by DECOS (CONCAWE and Cefic APA, 2013). This value is also in line numerically with that of the 2012 German AGS document BekGS 910 which set a Tolerated Risk value (ERB – Toleranzrisko) of 1.9 mg/m3 (0.6 ppm) as an 8 hour workplace limit for exposure to benzene. (AGS (2012) Whilst we do not agree with the approach used to set this limit, the AGS document indicates that this value would be expected to avoid haematological effects in workers. Again, the Registrants believe that the data justify this quantitative limit being applied as a DNEL rather than as a DMEL. 

Registrants referring to a DNEL of 0.6 ppm (8h TWA) will still be subject to the requirements of the Carcinogens and Mutagens Directive (Council Directive 1999/38/EC as amended) which requires substitution where feasible, exposure minimisation and monitoring of workers. LOA is continuing to monitor the data on benzene and will update its position as necessary.(For references see section 13 "Worker DNEL Explanation").

Oral

The oral route is not relevant to workers and a DN(M)EL will not be proposed.

Dermal

The risk management measures in place for carcinogenicity will provide adequate protection against the occurrence of dermal effects.

Inhalation

The risk management measures in place for carcinogenicity will provide adequate protection against the occurrence of inhalation effects.

Long-term local effects

The interim systemic long term threshold and risk management measures in place for carcinogenicity will provide adequate protection against the occurrence of local long-term effects.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Justification:
.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

Thresholds for consumers have not been derived as Benzene is registered as a transported intermediate under strictly controlled conditions, and consumer uses are not supported.