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Registration Dossier
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EC number: 205-089-1 | CAS number: 133-08-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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
no effects on fertility observed
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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:
Dimethylmalonate, CAS # 108-59-8
In the combined repeated dose reproduction/developmental screening test with DMM in Wistar rats
no treatment related changes in fertility index for males and females, gestation index, testes and
epididymis weights were observed compared to the control. No treatment related histopathological
changes of the sex organs or stages of spermatogenesis were reported (OECD SIDS, 2006).
The NOAEL for fertility corresponds therefore to the highest dose tested: 1000 mg/kg bw per day.
Effects on developmental toxicity
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
no effects on development observed
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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:
Dimethylmalonate, CAS # 108-59-8
The combined repeated dose reproduction/developmental screening test with DMM in Wistar rats
revealed no treatment related changes in the duration of gestation, the gestation index, parturition
and pre-implantatian loss compared to controls.
In the low dose group post-implantatian loss was increased and consequently the percentage of live
pups born was statistically significantly reduced compared to controls. These changes were
considered incidental and not treatment related as the effects were not observed in the mid and high
dose groups. No statistically significant differences between treated and control groups were
observed for the number of pregnancies, number of dams that littered, number of live litters, mean
litter size, mean viable litter size, sex ratio at birth, number of pups dead at first observatian or day
2 to 4 post partum, number of live pups at day 0, 3, and 4 post partum and the associated survival
indices. A significantly higher percentage of male pups and lower number of females an day 4 post
partum in the low dose group was considered incidental as no comparable change was observed in
the mid and high dose group or at other time intervals. The mean number and mean weights of male
and female pups as weIl as both sexes combined were otherwise not statistically significantly
different from controls. No statistically significant difference in the external abnormalities of life
and dead pups compared to controls was abserved at all dose levels. Maternal toxicity was restricted
to a reversible hepatocellular hypertrophy at 1000 mg/kg bw, with a matemal
NOAEL of 300 mg/kg bw. The NOAEL for developmental toxicity was 1000 mg/kg bw per day
(OECD SIDS, 2006).
Justification for classification or non-classification
Based on the available data for read across substance Dimethylmalonate, CAS # 108 -59 -8, there is no indication that Diethyl butylmalonate (CAS # 133 -08 -4) would require classification for toxicity to reproduction
Additional information
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.
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