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EC number: 201-162-7
CAS number: 78-96-6
No inhalation repeated dose toxicity study
is available. Thus, extrapolation from a OECD 408 oral study with DIPA
is performed: NOAEL = 100 mg/kg bw/d. Correction
of the NOAEL DIPA to the NOAEL MIPA based on the molecular weights: 100
mg/kg bw/d * (75.11 g/mol / 133.19 g/mol) = 56 mg/kg bw/d.
on the REACH R.8 guidance an inhalation volume for rats of 0.38 m3/kg
for 8 hr exposure is used. NOAEL
to NOAEC conversion: NOAEC
rats = 56 mg/kg/d / 0.38 m3/kg = 147 mg/m3.
oral absorption data are available for MIPA; hence data of DIPA are used
(90% oral absorption). 100% absorption is assumed for inhalation: NOAEC
rats = 147 mg/m3 x 90/100 = 133 mg/m3. Correction factor for
increased inhalation volume during work: NOAEC worker, 8hr = 6.7 m3/
10m3 x 132 mg/m3 = 89 mg/m3.
Long-term – inhalation, systemic effects
Supporting the DNEL derivation with the structurally similar DIPA,
a 28d repeated dose toxicity study based on hydrochloride salt of MIPA
(CAS 7780 -04 -3, OECD 422 study) in rats is available. The
derived DNEL value is 4.3 mg/m3 which is in line with the derived value
above of 3.6 mg/m3.
NOAEL: 300 mg/kg bw/day; Systemic toxicity of the test
substance for the F0 parental males based on some indications for a mild
An 8 h respiratory volume of 0.38 m3/kg bw for rats was used for
conversion into NOAEL upon inhalation exposure. Correction for activity
driven differences of respiratory volumes in workers compared to workers
in rest: 6.7 m3/10 m3. No oral absorption data are available for MIPA;
hence, data of DIPA are used (90% oral absorption). 100% absorption is
assumed for inhalation.
Modification of starting point: 0.38 m3/kg bw x 6.7 m3/10 m3 x
90/100. Correction for MW (75.1/111.6) between MIPA and the
hydrochloride salt of MIPA.
Modified dose-descriptor: 300 x 6.7 x 90 x 75.1/ (0.38 x 10 x 100
x 111.6) = 320 mg/m3
- Interspecies (other): 2.5 (No allometric scaling has to be
applied in case of oral to inhalation route to route extrapolation.)
- Intraspecies: 5 (Default assessment factor)
- Exposure duration: 6 (Default assessment factor for e
sub-acute to chronic duration of the study.)
- Dose response: 1
- Quality of database: 1
DNEL-Value: 320 mg/m3 / (2.5 x 5 x 6 x 1 x 1) = 4.3 mg/m3
NOAEL (90d, oral, DIPA) = 300 mg/kg
bw/d; correction for MW (75.1/133.19) between MIPA and DIPA --> modified
stating point: 300 x 75.1 / 133.19 = 169 mg/kg bw/day
there are no consumer uses for MIPA, CAS 78-96-6, the systemic long-term
oral DNEL for the general population might be necessary for an
assessment of indirect exposure of humans via the environment (ECHA GD
R.16, v 3.0, Feb 2016).
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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