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EC number: 413-110-2 | CAS number: 135861-56-2
The substance is not classified for human health.
Inhalation is not considered to be a significant route of exposure. An acute dermal toxicity study showed no toxicity and local effects are not considered to be a hazard as the substance is not a skin irritant or sensitiser.
Full exposure scenarios and risk characterisation are not required and therefore DNELs are not required for risk characterisation purposes. However, long-term systemic DNELs have been derived for inhalation and dermal routes for additional information.
The DNELs have been based on the OECD 421 Reproduction/Developmental Toxicity Screening test, which gives data on both general systemic toxicity and reproduction/developmental toxicity, rather than the 90 -day repeat dose study or 1 -generation reproduction study.
Inhalation long-term systemic DNEL:
A DNEL has been derived for long-term systemic effects by the inhalation route. The DNEL is derived by route-to-route extrapolation from an oral NO(A)EL of 1000 mg/kg bw/day for general toxicity and reproduction/developmental toxicity obtained in an OECD 421 Reproduction/Developmental Toxicity Screening Test.
A modification of the dose descriptor starting point (oral to inhalation) was conducted. It is assumed that the oral absorption rate is 50% of that of the inhalation absorption.
The corrected 8 hr inhalation NOAEC was 881.05 mg/m3.
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 human (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.
Figure R.8-3 Modification of the starting point:
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 (1 / 2) x (6.7 m3(8h) / 10 m3(8h))
= 881.05 mg/m3
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume (light activity)
sRVrat (8 h) : 0.38m3/kg bw
sRVhuman (8 h) : 6.7 m3/ person
wRV (8 h): 10 m3/ person
The appropriate assessment factors were then applied to give an overall assessment factor of 75.
DNEL (inhalation)= Inhalatory NOAEC / Overall assessment factor = 881.05 mg/m3/ 75 = 11.75 mg/m3
Dermal long-term systemic DNEL:
A long-term systemic DNEL has been derived by route-to-route extrapolation from an oral NO(A)EL of 1000 mg/kg bw/day for general toxicity and reproduction/developmental toxicity obtained in an OECD 421 Reproduction/Developmental Toxicity Screening Test.
The derived DNEL is 3.33 mg/kg bw/day.
The substance is used solely in industry in the manufacture of polyolefin compounds. The substance has no general population/consumer uses so exposure to the general population from use is not anticipated. Once the substance is bound into polyolefin compounds there should be no release, so exposure to the general population from release of the substance from final products is not anticipated.
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.
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