Registration Dossier
Registration Dossier
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EC number: 907-131-0 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
No carcinogenicity study on the test substance is available.
In a carcinogenicity study by Hiasa et al. (1990), chronic DEG (111 -46 -6) exposure did not result in neoplastic effects up to the highest concentration in rats. In addition no formation of bladder stones and possibly associated tumors was reported.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- 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:
- 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:
- 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 (CAS 111-46-6)
- Remarks:
- Correction for molecular weight not performed.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 210 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- mortality
- water consumption and compound intake
- Remarks on result:
- other: Result from read across (CAS 111-46-6)
- Remarks:
- Correction for molecular weight not performed.
Reference
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 studies regarding the carcinogenicity of the substance itself (target, EC 907-131-0) are available. Therefore, read across data on DEG (CAS: 111 -46 -6) has been used.
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.
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