Table 15.
Developmental and reproductive toxicity studies on chlorinated paraffins
| Species/ strain | Number of animals per group | CP specification | Duration | Administration | Dose levels (mg/kg bw per day) | Most sensitive endpoints | NOAEL (mg/kg bw per day) | LOAEL (mg/kg bw per day) | Reference |
|---|---|---|---|---|---|---|---|---|---|
| SCCPs | |||||||||
| Charles River COBS CD rats | 25/group | Carbon chain length not specified, 58% chlorination | GD6–19 | Gavage (corn oil) | 0, 100, 500, 2,000 |
M: clinical signs (decreased activity, matted, stained or oily fur, emaciated appearance, excessive salivation); D: shortened digits and/or adactyly, post‐implantation losses, decreased number of viable fetuses per dam |
M: 100 D: 500 |
M: 500 D: 2,000 |
IRDC (1982a)a, Serrone et al. (1987) |
| Dutch belted rabbits | 16/group | Carbon chain length not specified, 58% chlorination | GD6–27 | Gavage (corn oil) | 0, 10, 30, 100 |
M: no adverse effects D: increased number of resorptions |
M: 100 (NOEL) D: 10 |
M: – D: 30 |
IRDC (1983b)a, Serrone et al. (1987) |
| MCCPs | |||||||||
| Wistar rats |
5 males per group; 10 females per group |
Cereclor S52, C14–17, 52% chlorination | From 28 days prior do mating, to PND 21c | Diet | 0, 9, 90, 560 |
P: no adverse effects F: no adverse effects PN: decreased pup survival, subcutaneous haematoma/haemorrhage |
P: 560 (NOEL) F: 560 (NOEL) PN: 9 |
P: – F: – PN: 90 |
IRDC (1985)a, Serrone et al. (1987) |
| Sprague–Dawley rats | 12 or 17 animals/sex per group | Cereclor S52, C14–17, 52% chlorination | From 28 days prior to mating to PND 21d | Diet |
0, 21, 44, 84 (males); 0, 23, 47, 99 (females) |
P: ↑ relative liver weight (females), no effects (males) F: no adverse effects D: no adverse effects |
P: 47 (females), 84 (males) F: 84 (males), 99 (females) (NOEL) D: 99b (NOEL) |
P: 99 (females), – (males) F: – D: – |
CXR (2006)a |
| Charles River COBS CD rats | 25/group | Cereclor S52, C14–17, 52% chlorination | GD6–19 | Gavage (corn oil) | 0, 500, 2,000, 5,000 |
M: clinical signs (wet and/or matted fur anogenital region with staining, increased incidence of soft stool) D: no adverse effects |
M: 500 D: 5,000 |
M: 2,000 D: – |
IRDC (1984f), Serrone et al. (1987) |
| Dutch Belted rabbits | 16/group | Cereclor S52, C14–17, 52% chlorination | GD6–27 | Gavage (corn oil) | 0, 10, 30, 100 | M, D: no adverse effects |
M: 100 (NOEL) D: 100 (NOEL) |
M: – D: – |
IRDC (1983c), Serrone et al. (1987) |
| LCCPs | |||||||||
| Charles River COBS CD rats | 25/group | C22–26, 43% chlorination | GD6–19 | Gavage (corn oil) | 0, 500, 2,000, 5,000 | M, D: no adverse effects |
M: 5,000 (NOEL) D: 5,000 (NOEL) |
M: – D: – |
IRDC (1983d), Serrone et al. (1987) |
| Dutch belted rabbits | 16/group | C22–26, 43% chlorination | GD6–27 | Gavage (corn oil) | 0, 500, 2,000, 5,000 | M, D: no adverse effects |
M: 5,000 (NOEL) D: 5,000 (NOEL) |
M: – D: – |
IRDC (1982b), Serrone et al. (1987) |
| Charles River COBS CD rats | 25/group | Electrofine S70, C22–26, 70% chlorination | GD6–19 | Gavage (corn oil) | 0, 500, 2,000, 5,000 | M, D: no adverse effects |
M: 5,000 (NOEL) D: 5,000 (NOEL) |
M: – D: – |
IRDC (1984 g), Serrone et al. (1987) |
| Dutch belted rabbits | 16/group | Electrofine S70, C22–26, 70% chlorination | GD6–27 | Gavage (1% carboxymethyl cellulose in water) | 0, 100, 300, 1,000 | M, D: no adverse effects |
M: 1,000 (NOEL) D: 1,000 (NOEL) |
M: – D: – |
IRDC (1983e), Serrone et al. (1987) |
D: developmental toxicity; F: fertility effects; GD: gestational day; M: maternal toxicity; P: parental toxicity; PN: postnatal toxicity; PND: postnatal day; NOAEL: no‐observed adverse effect level; LOAEL: lowest‐observed adverse effect level; LCCPs: long‐chain chlorinated paraffins; MCCPs: medium‐chain chlorinated paraffins; SCCPs: short‐chain chlorinated paraffins.
Unpublished study report, see Documentation provided to EFSA.
As maternal dose.
Observation until PND70.
Observation until PND21.