Registration Dossier
Registration Dossier
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EC number: 404-360-3 | CAS number: 119313-12-1 CG 25-369; IRGACURE 369; TK 11-319
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.3 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the starting point (R.8 Figure R.8 -3):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL*(1/sRVrat)*ABSoral-rat/ABSinh-human)*(sRVhuman/wRV)
= oral N(L)OAL*(1/0.38 m3/kg/d)*(1/1)*6.7m3(8h)/10 m3 (8h))
ABS: Absoprtion
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume
ABSoral-rat: 1 [-]: worst case default
ABSinh-human: 1 [-]: worst case default
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to Chronic: REACH guidance R.8 (default)
- Justification:
- Not relevant for corrected inhalation DNEL: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 5
- Justification:
- Worker: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.8 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No absorption data is available, therefore a worst case modification factor of 1 is used: REACH guidance R.8 (default)
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to Chronic: REACH guidance R.8 (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to Human: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 5
- Justification:
- Worker: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Summary of results
The substance is of low acute oral (LD50> 5000 mg/kg bw) and low acute dermal toxicity (LD50> 2000 mg/kg bw). Additionally, the substance is not irritating to the skin and the eye when applied to rabbits. After application in a modified guinea pig maximisation test, no skin sensitising potential was observed. The product induced neither chromosome aberrations in-vitro in a mammalian cell line, nor in the micronucleus test in Chinese hamster. It was not mutagenic to different Salmonella typhimurium strains in the Ames test. Additionally, in a cell mutation assay at the thymidine kinase locus (tk+/-) in mouse lymphoma l5178y cells also no mutagenicity was seen. A study on chromosome aberration on Chinese hamster ovary cell line CCL 61 revealed no increase in chromosome aberrations. In accordance, upon in-vivo-treatment of Chinese hamster no increase of micronuclei in bone marrow cells was observed. Therefore, the substance has no genotoxic potential and a threshold can be expected.
A NOAEL of 100 mg/kg bw was determined for subacute oral exposure of rats for the endpoints of both developmental toxicity and general systemic toxicity.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the starting point (R.8 Figure R.8 -3):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL*(1/sRVrat)*ABSoral-rat/ABSinh-human)
= oral N(L)OAL*(1/1.15 m3/kg/d)*(1/1)
ABS: Absoprtion
sRV: standard Respiratory Volume
ABSoral-rat: 1 [-]: worst case default
ABSinh-human: 1 [-]: worst case default
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to Chronic: REACH guidance R.8 (default)
- Justification:
- Not relevant for corrected inhalation DNEL: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 10
- Justification:
- General population: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No absorption data is available, therefore a worst case modification factor of 1 is used: REACH guidance R.8 (default)
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to Chronic: REACH guidance R.8 (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to Human: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 10
- Justification:
- Generaql population: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data on absorption in the rat and in humans is available, therefore the dose descriptor starting point could not be corrected.
- AF for dose response relationship:
- 1
- Justification:
- No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to Chronic: REACH guidance R.8 (default)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to Human: REACH guidance R.8 (default)
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies remaining differences: REACH guidance R.8 (default)
- AF for intraspecies differences:
- 10
- Justification:
- Generaql population: REACH guidance R.8 (default)
- AF for the quality of the whole database:
- 1
- Justification:
- No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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
Please refer to the discussion on DNELs for workers mentioned above.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
