Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

All data discussed in this section were derived from toxicity studies with the hydrochloride of the same azo dye (read-across to CAS 118208-02-9).

A one-generation reproduction toxicity study according to OECD guideline 415 with oral administration (gavage) of the test substance in Wistar rats is available for the assessment of the toxicity to reproduction (BASF AG, 2000). Under the conditions of this study BASISCH GELB 8511 had no adverse effects on reproductive performance or fertility of the F0 parental animals of all substance-treated groups (2, 10 and 60 mg/kg body weight/day). Mating behavior, conception, gestation, parturition, lactation and weaning as well as gross findings were similar between the substance-treated rats and the corresponding controls. General effects in the F0 parental animals were limited to abnormal clinical findings. Respiratory sounds, discolored urine and a single case of fur smeared with urine were seen at 60 mg/kg body weight/day. The discoloration of the urine was related to the physical properties of the test compound (dyestuff) indicative for systemic availability. The affection of the respiratory system was probably due to an unintentional aspiration of the test substance as a consequence of attempts to vomit the test substance. Therefore, under the conditions of this study the NOAEL (no observed adverse effect level) for reproductive performance and fertility is 60 mg/kg body weight/day for the F0 parental rats. The NOAEL for general effects of the test substance is 10 mg/kg body weight/day for the F0 parental males and females.

Taken together, there is significant scientific evidence for the lack of reprotoxic effects of the test substance based on the results of a 90-day repeated dose toxicity study by oral administration in rats with adequate coverage of reproductive effects (BASF AG, 1999) and the above-mentioned one-generation reproduction toxicity study by oral administration in rats (BASF AG, 2000) with the hydrochloride of the same azo dye (Basazol Gelb 8511, CAS 118208-02-9). Furthermore, there is no evidence for a reprotoxic effect of the anion methansulfonate (NOAEL reproduction toxicity > 1000 mg/kg), as summarized in the "Supporting Documents for Initial Risk-Based Prioritization of High Production Volume Chemicals" (EPA, 2008). Therefore, data waiving for a pre-natal developmental toxicity study (OECD TG 414) and a two-generation reproduction toxicity study (OECD TG 416) was included.


Short description of key information:
In a one-generation reproduction toxicity study according to OECD guideline 415 no indications for an impaired reproductive performance and fertility were observed up to the high dose of 60 mg/kg body weight/day. Furthermore, there is significant scientific evidence for the lack of reprotoxic effects of the test substance based on the results of a 90-day repeated dose toxicity study by oral administration in rats with adequate coverage of reproductive effects (BASF AG, 1999). Therefore, a data waiving for a pre-natal developmental toxicity study (OECD TG 414) and a two-generation reproduction toxicity study (OECD TG 416) was included.

Effects on developmental toxicity

Description of key information
In a one-generation reproduction toxicity study according to OECD guideline 415 no indications for developmental toxicity were observed up to the high dose of 60 mg/kg body weight/day. Furthermore, there is significant scientific evidence for the lack of reprotoxic effects of the test substance based on the results of a 90-day repeated dose toxicity study by oral administration in rats with adequate coverage of reproductive effects (BASF AG, 1999). Therefore, a data waiving for a pre-natal developmental toxicity study (OECD TG 414) and a two-generation reproduction toxicity study (OECD TG 416) was included.
Additional information

All data discussed in this section were derived from toxicity studies with the hydrochloride of the same azo dye (read-across to CAS 118208-02-9).

A one-generation reproduction toxicity study according to OECD guideline 415 with oral administration (gavage) of the test substance in Wistar rats is available for the assessment of the developmental toxicity and teratogenicity (BASF AG, 2000).

General effects in the F0 parental animals were limited to abnormal clinical findings. Respiratory sounds, discolored urine and a single case of fur smeared with urine were seen at 60 mg/kg body weight/day. The discoloration of the urine was related to the physical properties of the test compound (dyestuff) indicative for systemic availability. The affection of the respiratory system was probably due to an unintentional aspiration of the test substance as a consequence of attempts to vomit the test substance. Substance-induced signs of developmental toxicity were not observed in progeny of the F0 parents at any dose level. The NOAEL for general effects of the test substance is 10 mg/kg body weight/day for the F0 parental males and females. The NOAEL for developmental toxicity (growth and development of the offspring) could be fixed at 60 mg/kg body weight/day for the F1 progeny. Thus, indications for impaired reproductive performance and fertility or for developmental toxicity were not observed up to the high dose of 60 mg/kg body weight/day.

Taken together, there is significant scientific evidence for the lack of reprotoxic effects of the test substance based on the results of a 90-day repeated dose toxicity study by oral administration in rats with adequate coverage of reproductive effects (BASF AG, 1999) and the above-mentioned one-generation reproduction toxicity study by oral administration in rats (BASF AG, 2000) with the hydrochloride of the same azo dye (Basazol Gelb 8511, CAS 118208-02-9). Furthermore, there is no evidence for a reprotoxic effect of the anion methansulfonate (NOAEL reproduction toxicity > 1000 mg/kg), as summarized in the "Supporting Documents for Initial Risk-Based Prioritization of High Production Volume Chemicals" (EPA, 2008). Therefore, data waiving for a pre-natal developmental toxicity study (OECD TG 414) and a two-generation reproduction toxicity study (OECD TG 416) was included.

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

- no classification required

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- no classification required