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1,2-Bis(2-methoxyethoxy)ethan
(CAS-NR.: 112-49-2)

Ausgabe: Mai 2002
Stand: November 2001

Mutagenicity:

There are no data available.

According to the EC classification criteria there is no classification possible (M: -).

Carcinogenicity:

There are no data available. Therefore according to the EC classification criteria there is no classification possible (C: -).

Reproductive

Toxicity/Fertility:

There is a continuous breeding study on mice available.

Swiss CD-1
Mice
20 pairs/ group		 drinking water 0; 440; 830 and 1470 mg/kg/d
Parental Toxicity: NOEL: 830 mg/kg bw/d
at 1470 mg/kg/d: liver weight -, pituitary weight ↓ (w)

Fertility Effects: NOAEL: 830 mg/kg bw/d
From 440 mg/kg: decrease of fertility index, live pups/ Litter and proportion of pups born alive with statistically

significant dose response trend (P < 0.05)
1470 mg/kg/d: mean pup bw ↓, female fertility index ↓,
live pups/litter ↓ *;proportion of pups born alive ↓ *,
litters per pair ↓ * (* P < 0.05 versus control)

 [Bossert et al. 1992]

In a 28 day subacute oral study on rats (0; 62.5; 250; 1000 mg/kg bw/d) there were at the highest dose clear toxic effects at the male gonades: Decrease in testes weight and testicular degeneration, azoospermia, isolatedfoci of necrosis of germinal epithelium).

The results of the continuous breeding study show that female fertility is decreasing with a statistically significant dose response trend starting at 440 mg/kg bw/d. In rats the 28 day application of 1000 mg/kg bw/d led to serious effects at the male gonades. According to the EC classification criteria a classification in category 2 (RF: 2) seems appropriate.

Reproductive Toxicity/Development:

There are four teratology studies available, 3 on mice and 1 on rabbits.

CD-1 mice
50 w/group		 gavage
g.d. 7-14		 3500 mg/kg/d
Maternal Toxicity: mortality 2/50

Fetal Effects: 100 % resorptions

 [Schuler et al. 1984]
CD-1 mice
26-28 w/gr.		 gavage
g.d. 6-15		 0; 250; 500; 1000 mg/kg/d
Maternal Toxicity: NOEL 250 mg/kg bw/d
from 500 mg/kg: relative liver weight -

Fetal Effects: NOEL 250 mg/kg bw/d
from 500 mg/kg: fetal bw/litter ↓ ,% live malformed fetuses/litter -(neural tube, craniofacial structures, axial skeleton)

 [George et al. 1987]
CD-1 mice
20 w/gr.		 gavage
g.d. 11		 713 mg/kg/d
Maternal Toxicity: NOEL 713 mg/kg bw/d

Fetal Effects: NOEL 713 mg/kg bw/d

 [Hardin & Eisenmann, 1987]
NZW- rabbits
22-25 w/gr.		 gavage
gd. 6-19
sacrifice
gd 30		 0; 75; 125; 175; 250 mg/kg/d
Maternal Toxicity: NOEL 125 mg/kg bw/d
from 175 mg/kg: bw gain ↓,gravid uterine weight ↓,
at 250 mg/kg: relative liver weight -

Fetal Effects: NOEL 125 mg/kg bw/d
From 175 mg/kg bw/d: prenatal mortality - , incidences of malformations -
at 250 mg/kg: preimplantational losses -

 [Schwetz et al. 1992]

In summary there is clear experimental evidence for teratogenic effects of the substance in mice and rabbits. based on these data and according to the EC classification criteria classification in categoriy 2 (RE: 2) is proposed.

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