2,2'-(ethylenedioxy)diethanol

Carcinogenicity

Description of key information

No carcinogenicity study on the test substance is available.

No carcinogenic effects were observed in a carcinogenicity study on DEG (read-across)

A NOAEL was recorded at 1160 mg/kg bw based on female water/food consumption and mortality.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to chapter 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Key result

Dose descriptor:

NOAEL

Effect level:

1 160 mg/kg bw/day

Based on:

test mat.

Sex:

female

Basis for effect level:

food consumption and compound intake

mortality

water consumption and compound intake

Remarks on result:

other: Result from read-across source CAS No. 111-46-6

Remarks:

Correction for molecular weight not performed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 160 mg/kg bw/day

Study duration:

chronic

Species:

rat

Carcinogenicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available information classification for carcinogenicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.

Additional information

No valid data for the test substance are available on carcinogenicity. Therefore a read-across is made to DEG.

In the key study (Hiasa et al., 1990) male and female Fischer 344 rats were administered 0, 1.25 or 2.5 % diethylene glycol in drinking water for two years after pretreatment with N-ethyl-N-hydroxyethylnitrosamine for tumor initiation. The intake of the test material was 0, 1210 or 2630 mg/kg bw/day for males and 0, 1160 or 2550 mg/kg bw/day for females.

At the high dose level drinking water consumption was clearly increased (females 17 %, males 25 %), and 19/50 males died compared to 13/50 in the control group. The serum lactate dehydrogenase activity was increased and serum urea was decreased in males, the creatine phosphokinase activity and the weights of the lung were increased in both sexes, but these changes were not reported to be clearly significant. In the urine no changes could be detected, but it was not mentioned if oxalate was measured. No bladder stones were reported. The incidences of tumors in all organs did not significantly differ between the three groups.In conclusion, this experiment did not provide evidence for a carcinogenic or kidney tumor promotion potential.

The systemic and carcinogenetic NOAEL was 1210 and 1160 mg/kg bw/day for males and females, respectively, based on increased drinking water consumption in both sexes and higher mortality in males.