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Key value for chemical safety assessment

Effects on fertility

Additional information

The following study does not provide reliable data or results because it was conducted at Industrial Bio-Test Laboratories, Inc. (Northbrook, Illinois, USA).

A 3-generation reproduction study employing albino rats fed diets containing either 40, 200, or 1,000 ppm of the test substance (Haley 1973). The following results were obtained during the investigation. Test and control group body weight data were similar throughout the investigation. There were no untoward behavioral reactions noted during the investigation. Gross autopsy performed on the animals found dead failed to reveal any relationship between the death of the animals and the exposure. Gross and histopathologic examinations of sacrificed parental animals from each generation, as well as organ weights and organ to body and organ to brain weight ratios, revealed no differences between treated and control animals which could be correlated with the ingestion of the test substance. No alterations in the reproductive performance of animals fed the test substance were observed which could be attributed to the test material ingestion. Test and control dams delivered essentially the same numbers of pups throughout the investigation.

The numbers of pups retained through weaning and pup survival indices revealed various reductions among treated groups in comparison to the control group. These reductions failed to reveal any consistent relationship with the level of the compound exposure and could not be correlated with the ingestion of the test substance.

All pups obtained during the investigation were judged to be free of gross external anomalies. Test and control pup body weights were similar throughout the investigation. Gross and histopathologic examinations conducted upon test and control progeny chosen randomly from the F1b litters revealed no findings that could be correlated with the exposure to the test substance.

Short description of key information:
No adverse effects on fertility was observed in a three generation feeding study of uncertain validiy with rats (Haley 1973). In the absence of significant systemic uptake, effects on reproductive organs and exposure, no further testing is considered necessary.

Effects on developmental toxicity

Description of key information
NOEAL (maternal and fetal) = 1000 mg/kg bw; CIBA 1991, OECD TG 414
Additional information

In a developmental toxicity study according to OECD TG 414 (CIBA, 1991) the test substance was tested for its embryotoxic, fetotoxic, and teratogenic potential in albino rats. The test article was administered by gavage in an aqueous solution of carboxymethylcellulose (0.5% w/w) at daily doses of 0 and 1000 mg/kg body weight to 24 mated nulliparous rats per group from day 6 through day 15 post-coitum (=p.c.) inclusive. The dose volume in both groups was 20 ml/kg body weight. Dams were killed on day 21 p.c. and fetuses removed by cesarean section for examination. There were no remarkable cage-side observations in dams during the study. Maternal body weights and food consumption were not affected by treatment. All animals survived to necropsy on day 21 p.c, except for one dam in the treated group, found dead on day 15 p.c. Necropsy revealed no pathological findings in this or any other animal. Three animals in the control group were not pregnant, and one in the treated group died on day 15 p.c. Thus the number of pregnant animals with viable fetuses at necropsy was 21 and 23 for the control and treated group respectively. The number of implantation sites and preimplantation losses were comparable in the two groups. Early resorption rate was not affected by treatment, and there were no late resorptions, abortions or dead fetuses. Thus the number of viable fetuses was comparable in the two groups. Fetal sex ratios and body weights were not affected by treatment. There were no treatment-related fetal external, visceral, or skeletal abnormalities. The no observed effect level of the test substance for rat dams and fetuses in this study was 1000 mg/kg body weight/day.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for developmental toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.


Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for developmental toxicity under Regulation (EC) No. 1272/2008

Additional information