Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA guidance directs the calculation of oral and dermal DNELs identically, assuming GI and dermal absorption to be 1.
AF for dose response relationship:
1
Justification:
A dose response is demonstrated in the two-year study (NCI, 1979)
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
pharmacodynamic (remainder)
AF for intraspecies differences:
5
Justification:
individual variability
AF for the quality of the whole database:
1
Justification:
adequate data
AF for remaining uncertainties:
1
Justification:
Expert opinions do not identify repeated dose toxicity as a risk of exposure
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

A category approach is used to evaluate the toxicity of the registered substance, benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane-1,2-diol (BECKOPOX(TM) EH 694). This oligomeric compound is comprised of cyclic acid anhydride structures, and so qualifies as a member of the category of selected cyclic acid anhydrides, similar to that established by World Health Organization (WHO) and reviewed in the Concise International Chemical Assessment Document (CICAD, Volume 75, in 2009). The category consists of 14 chemicals which have one or multiple anhydride groups. The substituent groups from the anhydride ring may be diverse in structure, ranging from hydrogen groups (succinic anhydride) to long alkyl chains (n-dodecenyl succinic anhydride) and pyromellitic anhydride. It is the anhydride functional group which is responsible for the toxicity of the substance. The Expert Group concluded that the critical effects of exposure to cyclic acid anhydride are sensitisation and work-related respiratory and dermal irritation.

A well-studied category member is phthalic anhydride. The NOAEL from a two year chronic cancer bioassay for phthalic anhydride is selected (National Cancer Institute, TR 159, 1979) as the point of departure for the calculation of the DNEL for BECKOPOX(TM) EH 694. The NOAEL is 500 mg/kg bw/d. An allometric scaling factor of 4 (accounting for rat to human), a pharmacodynamic factor of 2.5, and an individual variation factor among workers of 5 are applied, resulting in an overall AF of 50. The duration of the study is chronic, and a full data set is available for the category, requiring no additional AFs. No additional AFs are indicated. BECKOPOX(TM) EH 694 is an oligomeric substance and the bioavailability of the substance is estimated to be lower than that of phthalic anhydride. The DNEL is calculated to be 10.0 mg/kg bw/d.

Similar category substances are moderate dermal and respiratory sensitisers and so this substance is assumed to be a respiratory sensitiser. As such, the inhalatory and local dermal DNELs are addressed qualitatively. According to ECHA's . 2011, Guidance for information requirements and the chemical safety assessment, R.8, Characterisation of dose [concentration]-response for human health, Section R.8.7.2, "respiratory sensitisation is an endpoint for which no DNELs can be derived. The qualitative description should be taken forward to the risk characterisation." Calculation of a systemic inhalation DNEL is not appropriate when considering that the substance is a respiratory sensitiser. Risk management measures are very important in minimising the potential for worker exposure to respiratory sensitisers.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA guidance directs the calculation of oral and dermal DNELs identically, assuming GI and dermal absorption to be 1.
AF for dose response relationship:
1
Justification:
Dose response relationship seen in the study data
AF for differences in duration of exposure:
1
Justification:
chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
pharmacodynamic (remainder)
AF for intraspecies differences:
10
Justification:
individual variability
AF for the quality of the whole database:
1
Justification:
adequate
AF for remaining uncertainties:
1
Justification:
Expert groups do not identify repeated dose as a critical health effect
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

As discussed above, BECKOPOX(TM) EH 694 is a member of the cyclic acid anhydrides category, where the primary health risks are defined as sensitisation and work-related irritation reactions. The consumer has an extremely low chance of encountering a chemical environment similar to a worker. Dilution effects in the environment and the rapid breakdown of the anhydride to the acid form of the substance will occur. Dermal or respiratory sensitisation is unlikely.

A theoretical DNEL can be calculated for systemic long term oral exposure from a possible accidental spill (man via the environment). The point of departure is the NOAEL from a two year chronic cancer bioassay for a structural analogue, phthalic anhydride (National Cancer Institute, TR 159, 1979). The NOAEL is 500 mg/kg bw/d. The DNEL is calculated to be 5.0 mg/kg bw/d.