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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other toxicological threshold
Value:
0.035 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

See "Additional Information - Workers" below.

Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.14 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.035 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.14 mg/m³
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
Explanation for the modification of the dose descriptor starting point:

See "Additional Information - Workers" below.

Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Inhalation exposure is the most relevant route for assessing occupational risk in humans. Effects from repeated exposure of animals to analogous substances such as toluene diisocyanate (TDI) are limited to effects on the respiratory tract caused by local irritation. In a 2-year chronic toxicity and carcinogenicity study with vapour exposure of 2,4/2,6-TDI (80:20) to rats and mice a LOAEC of 0.36 mg/m³ (0.05 ppm) was determined for both species based on histopathological effects in the upper and lower respiratory tract (Owen, 1980 + 1986; Loeser, 1983).

According to the ECHA Guidance on information requirements and chemical safety assessment - chapter R.8 (May 2008) a national occupational exposure limit (OEL) may be used as a surrogate for a DNEL. The German Committee on Hazardous Substances (Ausschuss für Gefahrstoffe - AGS) derived an OEL (Arbeitsplatzgrenzwert - AGW) for the analogue, 2,4- and 2,6 -TDI which was substantiated in respective criteria documents (published in german on the website of the Federal Institute for Occupational Safety and Health (BAuA) - www.baua.de). According to the German Hazardous Substances Ordinance (Gefahrstoffverordnung) an AGW is a time-weighted average concentration in the workplace air, referring to a given period of time. The AGW states the concentration of a substance below which acute or chronic adverse health effects are generally not expected. AGWs are thus based exclusively on available occupational medical experience and toxicological findings.

For 2,4- and 2,6-TDI the AGS established an OEL of 0.035 mg/m³ (0.005 ppm) referring to an 8-hour exposure period. This OEL is used as a surrogate DNEL for long-term exposure for the substance as specific read across is utilised for associated endpoints. A ceiling limit value of 0.14 mg/m³ (0.02 ppm) is given for both isomers. This ceiling limit is used as a surrogate DNEL for short-term exposure. The German OELs for 2,4- and 2,6-TDI are in agreement with the threshold limit values (TLV-TWA: 0.036 mg/m³; TLV-STEL: 0.14 mg/m³) recommended by the American Conference of Governmental Industrial Hygienists (ACGIH, 2004). A plausibility check of the above mentioned national OELs revealed that the DNELs derived from animal data using assessment factors according to ECHA Guidance R.8 are in the same order of magnitude.  On the basis of associated read across, and given that the thresholds are deemed to be low enough as to provide for worst case, the OEL is assigned via read across to the substance subject to registration.

No DNEL for skin sensitization is calculated as the relationship between skin dose and response is not clear. Dermal exposure: Strong skin irritation is the leading acute effect of dermal exposure to the substance. Given the proposed low bioavailability of the substance via the skin, the derivation of DNELs for dermal exposure would therefore be misleading. In accordance to the ECHA Guidance on information requirements and chemical safety assessment - chapter R.8 (May 2008) a qualitative approach was applied or the assessment and control of risks due to skin irritation and sensitization (see above).

Finally, as discussed within the dossier, the substance is available within the EU only as a monomer in an imported polymer, with a low level of residual monomer present.  As such, exposure of workers to the substance as a monomer is considered to be negligible.

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
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

The test substance is imported only as a monomer in an imported polymer, with a low level of residual monomer present.  The imported polymer is used in the manufacture of associated articles.  As such, exposure of the consumer to the substance as a monomer is considered to be negligible.