Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
10 mg/kg bw/day
Study duration:
subacute
Species:
mouse
Additional information

Pitch coal tar, high temp. is a genotoxic carcinogen with adequate risk management measures implemented. Thus according to REACH regulation, studies on reproductive toxicity are not required.

Benzo(a)pyrene is present in coal tar pitch, high temp. in a concentration up to 1.5%. In the absence of data for coal tar pitch, high temp., reproductive effects of BaP may be used to characterise reproductive potency of pitch, coal tar, high temp.


Short description of key information:
Studies on reproductive toxicity using pitch, coal tar, high temp. are not available. In a fertility study with benzo(a)pyrene following no guideline (exposure of pregnant dams from day 7 to day 16 of gestation, monitoring of reproductive success and development of F1 offspring and reproductive performance of F1 males and females) adverse effects on fertility were observed even at the lowest concentration tested (10 mg/kg bw/d).

Justification for classification or non-classification

Benzo(a)pyrene is classified as reproductive toxicant Cat. 1B. Based on a content of up to 1.5% of benzo(a)pyrene, pitch, coal tar, high-temp., is classified as reproductive toxicant Cat. 1B by the registrant.