Registration Dossier

Administrative data

Description of key information

There is no data available for diethyl butylmalonate (CAS # 133 -08 -4). For C&L purposes, the following data available for structurally similar substances cited in the 2006 OECD SIDS “malonic acid diesters” (UNEP Publications, Final 10/2006) is suitable for read across:

Dimethylmalonate, CAS # 108-59-8

LD50(oral) > 2000 mg/kg

LD50(dermal) > 2000 mg/kg

 

Diethylmalonate, CAS # 105-53 -3

LD50(oral) = 15794 mg/kg

LD50(dermal) > 16960 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

There is no data available for diethyl butylmalonate (CAS # 133 -08 -4). For C&L purposes, the following data available for structurally similar substances cited in the 2006 OECD SIDS “malonic acid diesters” (UNEP Publications, Final 10/2006) is suitable for read across:

Acute toxicity, oral:

Dimethylmalonate, CAS # 108-59-8

For DMM a GLP- limit study was conducted in rats and revealed na substance related mortality,

clinical symptoms, bady weight changes or macroscapic findings at the limit dose of 2000 mg/kg

bw (OECD SIDS, 2006).

Diethylmalonate, CAS # 105-53-3

Smyth et at. (1969) report an acute oral toxicity in rats of DEM of 15 794 mg/kg bw. This study was

not conducted according to modern guidelines, but corroborates the study with DMM (OECD SIDS, 2006).

Acute toxicity, inhalation:

Diethylmalonate, CAS # 105-53-3

A limited inhalation study reported na deaths in rats that were exposed to concentrated vapors of

DEM for 8 h. No details were reported. (Smyth et al., 1969 cited in OECD SIDS, 2006).

Acute toxicity: dermal:

Dimethylmalonate, CAS # 108-59-8

A limit study according to OECD TG 402 and GLP with DMM revealed no mortality, na clinical

signs, na local irritation at the site of contact, na effects an body weight and na macroscopic organ

changes attributable to the test substance at the limit dose of 2000 mg/kg bw. (OECD SIDS, 2006).

Diethylmalonate, CAS # 105-53-3

For DEM an acute dermal toxicity in rabbits of > 16 960 mg/kg bw with 24 h of exposure was

reported. (Smyth et al., 1969). This study was not conducted according to modern guidelines, but

corrobarates the study with DMM (OECD SIDS, 2006)

Justification for classification or non-classification

Based on the available data for read across substances Dimethylmalonate, CAS # 108-59-8 and Diethylmalonate, CAS # 105 -53 -3, there is no indication that Diethyl butylmalonate (CAS # 133 -08 -4) would require classification for acute toxicity.