Registration Dossier
Registration Dossier
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EC number: 700-334-3 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.87 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A modification of the dose dsecrptior starting point (oral to inhalation) was conducted. It is assumed as a worst case assumption that the oral absorption rate is 50% of that of the inhalation absorption.
The corrected dose descriptor (NOAEC) for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure was performed using the modification of starting point equation as given in Figure R. 8-3 (see below) for workers (in the case of 8 hour exposure/day).
Default parameters for rats and humans (for 8 hour exposure) were used for the modification of starting point under the allometric scaling principle as given in Table R. 8-2 of the above ECHA guidance.
Conversion of an oral rate N(L)OAEL into a correct inhalatory N(L)OAEC to assess human inhalatory exposure:
For workers (in case of 8h exposure/day):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL x (1 / sRVrat) x (ABSoral-rat / ABSinh-human) x (sRVhuman / wRV)
Corrected inhalatory N(L)OAEC= 1000 mg/kg bw/day x (1 / 0.38 m3/kg/d) x (0.5) x (6.7 m3(8h) / 10 m3(8h)) = 881 mg/m3
Where:
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume (light activity)
Default parametrs:
sRVrat (8 h): 0.38m3/kg bw
sRVhuman (8 h): 6.7 m3/ person
wRV (8 h): 10 m3/ person
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL the default assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for subacute to chronic studies (OECD 422 study assessed as subacute study as most conservative value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling not required as the differences in allometry (respiration rate and rate to human body sizes) were considered in the conversion from oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Quality of data considered to be reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been applied as the OECD 422 study (providing the repeat dose toxicity data) has been read-across from a structurally similar analogue substance. An additional AF has been considered applicable based on any minor potential differences between the substances.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute inhalation study has been conducted so no results are available to derive an acute inhalation DNEL for systemic effects.
Inhalation is not considered to be a significant route of exposure for workers based on the substance being of low volatility and use patterns (see inhalation data waivers for details).
An acute DNEL for acute systemic effects is therefore not considered to be necessary.
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is considered that dermal absorption will not be higher than oral absorption, therefore no default factor (i. e. factor 1) should be introduced when performing oral-to dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL the default assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for subacute to chronic studies (OECD 422 study assessed as subacute study as most conservative value)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for allometric scaling based on rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- Quality of data considered to be reliable.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been applied as the OECD 422 study (providing the repeat dose toxicity data) has been read-across from a structurally similar analogue substance. An additional AF has been considered applicable based on any minor potential differences between the substances.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL for long-term systemic effects have been derived for both inhalation and dermal routes, based on the results of an OECD 422 study on a structural analogue substance. The NOAEL in this study was 1000 mg/kg bw/day (the top dose tested) but DNELs have been derived as a worst case assessment.
Inhalation is also not considered to be a significant route of exposure.
The substance is a skin sensitiser (moderate hazard) and local dermal effects will be assessed in a qualitative assessment.
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
DNEL values have not be calculated for the general population/consumers, as the substance will not be made available to the general public and there is no potential for exposure to the substance for consumers. The substance is consumed during the polymerisation process into contact lens material. Once polymerised, there is no degradation. Under normal conditions of use, the substance is not leached out of the finished product.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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