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EC number: 200-300-3
CAS number: 56-93-9
on acute toxicity are available for the oral, inhalation and dermal
route. BTMAC is classified for acute oral and dermal toxicity Hazard
Category 3 as well as inhalation toxicity Hazard Category 4.
is not classified for skin or eye irritation, nor for skin sensitization.
relevant for long-term toxicity are available from an oral sub-chronic
toxicity study and a developmental toxicity study, both in rats.
of the relevant dose descriptors:
= 25 mg/kg bw/day: 90 d Repeated Dose Toxicity Study, rat, oral (gavage)
= 20 mg/kg bw/d: Prenatal Developmental Toxicity Test, rat, oral (gavage)
for the eyes
additional hazard was listed for acute eye effects, since 3 of 6 animals
in the acute eye irritation study died after dosing, even though no eye
irritation was observed.
of the relevant dose descriptors to the correct starting point:
data exist on differences in bioavailability following oral or dermal
exposure between experimental animals and humans, and a similar
bioavailability is assumed by default.
inhalatory exposure as a worst case assumption a 100% absorption is
assumed in absence of any experimental data (Guidance on Information
Requirements and Chemical Safety Assessment, R8).
oral to inhalation: AF 2
chemical safety assessment a dermal absorption rate of 100% is assumed
as a worst case value (Guidance on Information Requirements and Chemical
Safety Assessment, R8).
long term systemic effects
Allometric scaling (inhalation)
No allometric scaling rat to humans for inhalation - differences in respiratory volume are already included in route-to-route extrapolation (ECHA 2008).
Allometric scaling (dermal)
Allometric scaling rat to humans AF 4 (ECHA 2008).
Remaining interspecies differences
Default AF for remaining interspecies differences
Default AF for workers
Differences in duration of exposure (90 d repeated dose toxicity study)
Default assessment factor for extrapolation from subchronic to chronic
Differences in duration of exposure (prenatal developmental toxicity study)
No time extrapolation is required since the susceptible window is fully covered.
Dose response and endpoint specific/severity
The NOAELs are reliable. No adjustment is required.
Quality of whole database
The studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
No uncertainties remain.
derived from oral repeated dose toxicity NOAEL (90-d study, rat, OECD
long-term for dermal route (systemic): 0.25 mg/kg bw/d
value: 25 mg/kg bw/d
of original study: oral
descriptor starting point after route-to-route extrapolation: 25 mg/kg
AF 4*2.5*5*2*1*1*1 = 100
long-term for inhalation route (systemic): 0.88 mg/m³
descriptor starting point after route-to-route extrapolation: 22.04 mg/m³
workers the corrected inhalatory NOEC is calculated according to the
inhalatory NOAEC = oral NOAEL x 1/sRVratx ABSoral-rat/ ABSinh-humanx
25 x 1/0.38 x 50/100 x 6.7/10
corrected inhalatory NOAECworker (8h) is therefore:
22.04 mg/m³ (8h-TWA)
AF: 1*2.5*5*2*1*1*1 = 25
DNEL does not address the potential for local irritation. The risk
characterisation will consider whether specific risk management measures
are necessary to protect against local effects.
derived from oral prenatal developmental toxicity NOAEL (rat, OECD
long-term for dermal route (systemic): 0.4 mg/kg bw/d
value: 20 mg/kg bw/d
descriptor starting point after route-to-route extrapolation: 20 mg/kg
AF 4*2.5*5*1*1*1*1 = 50
long-term for inhalation route (systemic): 1.41 mg/m³
descriptor starting point after route-to-route extrapolation: 17.63 mg/m³
20 x 1/0.38 x 50/100 x 6.7/10
17.63 mg/m³ (8h-TWA)
AF: 1*2.5*5*1*1*1*1 = 12.5
DNELs for developmental toxicity were higher than those for repeated
dose toxicity. Thus, the repeated dose toxicity-DNELs are also
protective for development.
No DNEL derived for general population, as no consumer exposure is
anticipated. Substance is used as a catalyst only in industrial settings.
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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