Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 298-577-9 | CAS number: 93819-94-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.31 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
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:
- 0.58 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- LOAEL
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
Read-across from other, structurally closely related ZDDPs is justified because of structural similarity and analogy of properties and effects.
1. Relevant Toxicology Data, exposure pattern and route
The dermal repeat dose toxicity of this substance was evaluated with rats at doses as high as 350 mg/kg/day for up to 28 consecutive days. This study is considered to be the relevant dose descriptor for the dermal route of exposure for workers. A LOAEL of 70mg/kg bw/day was established.
For inhalation, the oral toxicity study (OECD 422) carried out on a structurally similar material was considered to be the appropriate hazard information, from which appropriate corrected descriptors could be derived.
2. Mode of action
No non-threshold mode of action is associated with this substance, in particular, the test substance has no genotoxic potential.
3. Correction of dose descriptor
Dermal: The calculation of the DNEL is based on the results of repeated dose dermal toxicity study in rats. LOAEL = 70 mg/kg/d.
Inhalation: DNEL calculation was based on the results of an OECD 422 toxicity study in rats. NOAEL (oral) = 160 mg/kg/d. Test material purity is 91% and it was taken into account when calculating DNEL.
4. Application of assessment factors
Dermal route: Based on REACH guidance, chapter r8, default values to correct for differences in metabolic rate (allometric scaling, rat to human) of 4 was used; regarding the additional factor for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate and toxicodynamic differences, the default factor for remaining uncertainties of 2.5 could be reduced to 1 for the effects on the skin (REACH, chapter r8, page 33). The assessment factor for duration extrapolation was 6. The assessment factor of 5 was adopted for intraspecies differences. DNEL (Derived No Effect Level) = 0.58 mg/kg bw/day.
Inhalation route: The inhalation route was extrapolated by oral route information in the absence of data for this administration route. The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m3/kg for 8 hours exposure of workers, see Table R. 8-2 in Section R.8.4.2, REACH guidance, chapter r8). For workers the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor derives from the inhalative volumes in 8 hours under the respective conditions (6.7 m3 for base level, 10 m3 for light activity). NOAEL (corrected) = NOAEL (oral) ÷0.38 m3/kg*(ABS rat-oral ÷ ABS human-inhalation) x 6.7 ÷ 10.3 = 273.9 m3/kg Assessment Factors: Based on REACH guidance, chapter r8, default values to correct for differences in metabolic rate (allometric scaling, rat to human) of 1 was used; The assessment factor for duration extrapolation was 6. The assessment factor of 5 was adopted for intraspecies differences. DNEL (inhalation): NOAEL (inhalation) / Sum of assessment factors applicable = 273.9 m3/kg / 30 = 9.12 mg/ m3/d Purity taken into account: DNEL = 9.12 * 91% = 8.31mg/ m3/d
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.11 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEC
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:
- 0.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 240
- Modified dose descriptor starting point:
- LOAEL
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:
- 0.24 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
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
1. Relevant Toxicology Data, exposure pattern and route
The dermal repeat dose toxicity of this substance was evaluated with rats at doses as high as 350 mg/kg/day for up to 28 consecutive days. This study is considered to be the relevant dose descriptor for the dermal route of exposure for the general population. A LOAEL of 70mg/kg bw/day was established.
For inhalation, the oral toxicity study (OECD 422) carried out on a structurally similar material was considered to be the appropriate hazard information, from which appropriate corrected descriptors could be derived.
For the oral route of exposure, the abovementioned OECD 422 on a structurally similar material was considered to be the appropriate hazard information from which to derive suitable DNELS for the general population.
2. Mode of action
No non-threshold mode of action is associated with this substance, in particular, the test substance has no genotoxic potential.
3. Correction of dose descriptor
Dermal route: DNEL was calculated based on the results of a repeated dose dermal toxicity study in rats. LOAEL = 70 mg/kg/d.
Oral route: DNEL was calculated based on the results of an OECD 422 toxicity study in rats. NOAEL (oral) = 160 mg/kg/d.
Inhalation route: DNEL was calculated based on the results of an OECD 422 toxicity study in rats. NOAEL (oral) = 160 mg/kg/d. Test material purity is 91%. The inhalation route was extrapolated by oral route information in the absence of data for this administration route. The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure of general public, see Table R. 8-2 in Section R.8.4.2, REACH guidance, chapter r8). NOAEL (corrected) = NOAEL (oral) ÷1.15 = 139.1 m3/kg
4. Application of assessment factors
Dermal route: Based on REACH guidance, chapter r8, default values to correct for differences in metabolic rate (allometric scaling, rat to human) of 4 was used; Regarding the additional factor for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate and toxicodynamic differences, the default factor for remaining uncertainties of 2.5 could be reduced to 1 for the effects on the skin (REACH, chapter r8, page 33). The assessment factor for duration extrapolation was 6. The assessment factor of 10 was adopted for intraspecies differences.
Oral route: Based on REACH guidance, chapter r8, default values to correct for differences in metabolic rate (allometric scaling 4) and an additional factor of 2.5 for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part) was used. The assessment factor for duration extrapolation was 6. The assessment factor of 10 was adopted for intraspecies differences. NOAEL (dermal): NOAEL (oral) / Sum of assessment factors applicable = 160kg bw / 600 = 0.27 mg/kg/d Taken purity into account: 0.27 mg/kg * 91% = 0.24 mg/kg/d
Inhalation route: Based on REACH guidance, chapter r8, default values to correct for differences in metabolic rate (allometric scaling, rat to human) of 1 was used; The assessment factor for duration extrapolation was 6. The assessment factor of 10 was adopted for intraspecies differences. DNEL (inhalation): NOAEL (inhalation) / Sum of assessment factors applicable =139.1 m3/kg / 60 = 2.32 mg/ m3/d Taken purity into account: DNEL = 2.32 * 91% = 2.11 mg/ m3/d
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.
