Table 5.
Previous assessments on short‐chain chlorinated paraffins (C10–13)
| Organisation | TDI (μg/kg bw per day) | NOAEL (mg/kg bw per day) | Critical endpoint (s) | Relevant Study | Study reference | Uncertainty factor | Remarks |
|---|---|---|---|---|---|---|---|
| WHO/IPCS (1996) |
100 (for non‐neoplastic effects) |
10 | ↑ liver and kidney weights and hypertrophy of the liver and thyroid | 90‐day rat study | IRDC (1984)a | 100 | Uncertainty factor for intra‐ and interspecies variation (10 × 10) |
| WHO/IPCS (1996) |
11 (for neoplastic effects) |
11 (the estimated dose associated with a 5% increase in tumour incidence) | hepatocellular adenomas or carcinomas (combined) | 2‐year mouse study | NTP (1986a), Bucher et al. (1987) | 1,000 | Uncertainty factor for non‐genotoxic carcinogen |
| OECD (2000) | Not derived | 100 | ↓ body weight gain and increased kidney weight | Rat studies | n.a. | n.a. | – |
| EU‐RAR (2000) | Not derived |
100 500 |
General non‐specific toxicity Developmental effects |
Rat and mouse studies |
n.a. n.a. |
n.a. | – |
| Health Canada (2008) | Not derived | 100 (LOAEL) |
↑ liver and kidney weights and hypertrophy of the liver and thyroid |
90‐day rat study | IRDC (1984)b | n.a. | – |
| UK‐COT (2009) | 30 | 10 | ↑ kidney weight, mild nephritis in males and brown pigmentation in renal tubules in females | 90‐day rat studies | As cited in EU‐RAR (1999)c | 300 | Uncertainty factor for intra‐ (10) and interspecies (10) variations, and an additional uncertainty factor of 3 for a non‐chronic study |
NOAEL: no‐observed adverse effect level; LOAEL: lowest‐observed adverse effect level; TDI: tolerable daily intake; bw: body weight.
IRDC, 1984. 13‐week oral (gavage) toxicity study in rats with combined excretion, tissue level and elimination studies: determination of excretion, tissue level and elimination after single oral (gavage) administration to rats. Chlorinated paraffin: 58% chlorination of short‐chain length n‐paraffins; 14C‐labelled CP. Mattawan, Michigan, International Research and Development Corporation, 350 pp (Report No. 438‐029/022). As cited in WHO‐IPCS (1996). Note: Study report also provided to EFSA (IRDC, 1984b, see Documentation provided to EFSA).
IRDC, 1984. 13‐week dietary toxicity study in rats with combined excretion, tissue level and elimination studies/determination of excretion, tissue level and elimination after single oral (gavage) administration to rats. Chlorinated paraffin: 70% chlorination of long‐chain length n‐paraffins; 14C‐labelled CP. Mattawan, Michigan, International Research and Development Corporation, 316 pp (Report No. 438‐027/024). As cited in Health Canada (2008). Note: Study report also provided to EFSA (IRDC, 1984e, see Documentation provided to EFSA).
ECB (European Chemicals Bureau), 1999. Alkanes, C10–13, chloro. European Union Risk Assessment Report. As cited in COPT (2009). Note: report cited in this opinion as EU‐RAR (2000).