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Key value for chemical safety assessment

Effects on fertility

Description of key information

In an oral reproduction toxicity study on mice no adverse effects on reproductive performance were observed and the NOAEL were established to be 6780 mg/kg bw/day (read across data)

Link to relevant study records
Reference
Endpoint:
two-generation reproductive toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
6 780 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall effects
Remarks on result:
other: Result from read across (CAS 112-27-6)
Remarks:
Correction for molecular weight not performed.
Key result
Critical effects observed:
no
Key result
Dose descriptor:
NOAEL
Effect level:
6 780 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall effects
Remarks on result:
other: Result from read across (CAS 112-27-6)
Remarks:
Correction for molecular weight not performed
Key result
Critical effects observed:
no
Key result
Generation:
F1
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
Result from read across (CAS 112-27-6)
Key result
Critical effects observed:
no
Key result
Generation:
F2
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
Result from read across (CAS 112-27-6)
Key result
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
6 780 mg/kg bw/day
Study duration:
subacute
Species:
mouse
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

 There is are no studies available on the fertility of the substance itself (target, EC 907-131-0). Therefore, read across data on main constituent TEG (CAS: 112 -27 -6) has been used.

 

The test substance was tested in a two-generation study (Bossert et al., 1992). Male and female mice were given the test substance via the drinking water in concentrations of 0.3, 1.5 and 2% (= 590, 3300 and 6780 mg/kg bw/day). The test substance was not a reproductive toxicant in either generation of mice when administered at concentrations of up to 3%, although developmental toxicity was noted in the first generation as reduced pup body weight. The NOAEL for the parental animals was found to be 6780 mg/kg bw/day; NOAEL for the F1 generation was also 6780 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

In an oral developmental toxicity study on mice an effect on fetal body weight was observed. The NOAEL was established to be 565 mg/kg bw/day (read across data)

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Additional information is available in the endpoint summaries and the read-across justification (see section 13).
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOEL
Remarks:
mouse
Effect level:
5 other: mL/kg/day
Based on:
test mat.
Basis for effect level:
organ weights and organ / body weight ratios
Remarks on result:
other: Result from read across (CAS 112-27-6)
Remarks:
Correction for molecular weight not performed
Dose descriptor:
NOEL
Remarks:
rat
Effect level:
1 other: mL/kg/day
Based on:
test mat.
Basis for effect level:
body weight and weight gain
food consumption and compound intake
organ weights and organ / body weight ratios
water consumption and compound intake
Remarks on result:
other: Result from read across (CAS 112-27-6)
Remarks:
Correction for molecular weight not performed
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOEL
Remarks:
mouse
Effect level:
0.5 other: mL/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes
Remarks on result:
other: Result from read across (CAS 112-27-6)
Remarks:
Correction for molecular weight not performed.
Dose descriptor:
NOEL
Remarks:
rat
Effect level:
5 other: mL/kg/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes
Remarks on result:
other: Result from read across (CAS 112-27-6)
Remarks:
Correction for molecular weight not performed.
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
not specified
Developmental effects observed:
yes
Lowest effective dose / conc.:
10 other: mL/kg bw/day
Treatment related:
yes
Relation to maternal toxicity:
developmental effects as a secondary non-specific consequence of maternal toxicity effects
Dose response relationship:
yes
Relevant for humans:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
565 mg/kg bw/day
Study duration:
subacute
Species:
mouse
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

There is are no studies available on the developmental toxicity / teratogenicity of the substance itself (target, EC 907-131-0). Therefore, read across data on main constituent TEG (CAS: 112 -27 -6) and on DEG (CAS 111 -46 -6) has been used.

A developmental toxicity study with mice was reported (BRRC, 1990). Time-pregnant mice were given concentrations of 0.5, 5 and 10 mL/kg/d from gestation day 6 -15 via gavage (study duration: until gestation day 18). The administration of TEG resulted in maternal toxicity at 10 mL/kg/d and fetotoxicity at 10 and 5 mL/kg/d. The ratio of the adult lowest observable effect level to the developmental lowest observable effect level was greater than 1 indicating preferential susceptibility of the developing mouse fetus to the test substance under these study conditions. The NOEL for maternal toxicity was 5 mL/kg/d and the NOEL for developmental toxicity was 0.5 mL/kg/d (equivalent to 565 mg/kg bw/day).

TEG was tested by gavage in rats. Doses of 1, 5 and 10 mL/kg were given to time-pregnant rats from gestation day 6 - 15 (study duration: 21 days). Maternal toxicity was seen at 5 and 10 mL/kg and fetotoxicity was observed at 10 mL/kg/day. There was a slight treatment-related increase in the incidence of two minor skeletal malformations at the high dose group. The NOEL for maternal toxicity was 1 mL/kg/d, and the NOEL for developmental toxicity was 5 mL/kg/d (BRRC, 1991).

For developmental toxicity in rabbits, read-across from DEG was employed. Prenatal toxicity of orally administered DEG in rabbits was investigated in a study according to OECD TG 414 (BASF, 1989; Hellwig et al., 1995). DEG was administered by gavage to pregnant rabbits in daily doses of 100, 400 and 1000 mg/kg bw /day. From G7 through GD 19. Treatment-related effects on body weight parameters or clinical signs were not observed in the dams at any dose. Necropsy did not reveal any findings associated with the test item, and the gestational parameters were not significantly altered in the treated groups vs. the control group. Up to and including a dose of 1000 mg/kg bw/day, no signs of embryo-/fetotoxicity were observed; especially no teratogenic effects could be detected.

Justification for classification or non-classification

Based on the available data classification for reproductive toxicity is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information