Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
1 016 mg/m³
Explanation for the modification of the dose descriptor starting point:
startpoint correction according to R 8.4.2. with a factor of 0,503 (total)
AF for dose response relationship:
1
Justification:
NOAEL as starting point, R 8.4.3.1.
AF for differences in duration of exposure:
2
Justification:
default for subchronic to chronic extrapolation, T-R.8-5
AF for interspecies differences (allometric scaling):
1
Justification:
default of guidance R.8.4.3.1.
AF for other interspecies differences:
2.5
Justification:
guidance R.8.4.3.1
AF for intraspecies differences:
5
Justification:
guidance R.8.4.3.1
AF for the quality of the whole database:
1
Justification:
recent guideline study, Klimish 1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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
DNEL derivation method:
ECHA REACH Guidance

Workers - Hazard via dermal 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:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
582 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
starting with the NOAEL of 582 mg/kg bw/d (=2020 mg/m3) of the inhalative 90 d study, both for inhalative and dermal exposure 100% absorption is assumed. According to the guidance R.8 no further starting point correction is required.
AF for dose response relationship:
1
Justification:
NOAEL as starting point, R 8.4.3.1
AF for differences in duration of exposure:
2
Justification:
guidance T-R.8-5
AF for interspecies differences (allometric scaling):
4
Justification:
guidance R.8.4.3.1, default for systemic effects
AF for other interspecies differences:
2.5
Justification:
guidance R.8.4.3.1
AF for intraspecies differences:
5
Justification:
guidance R.8
AF for the quality of the whole database:
1
Justification:
recent guideline study, Klimish 1
AF for remaining uncertainties:
1
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Discussion

> 95% of the substance manufactured are used on-site. For this usage the substance is contained in closed industry-scale machinery and there is practically no open handling of the substance. For commercial applications most customers have confirmed intermediate usage in accordance with article 18.4, REACH. As a consequence, human exposure is not expected to be likely.

Acute and local effects

Due to the controlled conditions of exposure, there is no human data available on acute local effects. Animal testing shows severe eye irritation, but the data available is not suitable for a quantitative approach. An inhalative 90d study showed no inflammation of the nose, but histopathology revealed some minimal to mild inflammation of the respiratory tract at the highest dose, these effects were not considered to be of toxicological significance.

Excepting eye irritation, there is no evidence of adverse acute or local effects. In any case the long-term systemic inhalative and dermal DNEL will provide adequate protection also for any acute and local effects as well.

Hazards for the Eye

The substance was shown to be an eye irritant in animal experiments, but data do not allow quantitative analysis. In addition to the controlled exposure conditions prevailing eye protection is advised.

Long-term inhalative, systemic effects

The inhalative 90d study resulted in a DNEL of 2020 mg/m3 corresponding to 582 mg/kg bw/d. Using standard ECHA guidance adjustment factors, a DNEL of 40,6 mg/m3 was derived.

Long-term dermal, systemic effects

Due to the operational exposure conditions of the substance, dermal exposure to Norbornene is not likely, much less long-term exposure. As a conservative approach, a DNEL was derived based on the available 90d study using standard adjustment factots of ECHA guidance R.8

General Population - Hazard via inhalation route

Systemic effects

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

General Population - Hazard via dermal route

Systemic effects

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

Local effects

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

General Population - Hazard via oral route

Systemic effects

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance is used only as monomer and intermediate under strictly controlled conditions. No uses or properties suitable for a consumer application are known. As a consequence the substance does not come into contact with the general population either directly or through indirect exposure through the invironment.The derivation of a DNEL is therefore not required.