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EC number: 306-227-4 | CAS number: 96690-34-5
LOAEL (rat) = 10 mg/kg bw/day
RA from Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates (CAS 80939-62-4)
Justification for Read-across
There are no data available regarding repeated dose toxicity for Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates (CAS 96690-34-5). Therefore, read-across from the appropriate substance Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates (CAS 80939-62-4) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfill the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.6. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed analogue justification for the read-across approach is provided in IUCLID Section 13.
In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD 422 and under GLP conditions, 10 male and 10 female Wistar rats received Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates (CAS 80939-62-4) by gavage at dose levels of 10, 30 and 100 mg/kg bw/day; dose selection was based on the results of a preliminary range-finding study (WIL Research, 2013). Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to the day prior to scheduled necropsy. Females were exposed for 41 - 54 days, i.e. during 2 weeks prior to mating, during mating, during gestation, and during at least 4 days of lactation (up to the day prior to scheduled necropsy). Parental animals were observed at least twice daily for mortality and daily for evidence of clinical signs. Body weights and food consumption were recorded weekly. At necropsy, haematological and clinical biochemistry parameters were determined. In addition, organ samples were taken from all animals and the organ weights were recorded from 5 animals/sex/dose level at necropsy. Histopathological examination was performed for control and high-dose groups, and for all dose groups when gross lesions were observed.
Mortality and clinical signs were not observed up to the end of the study period. Slightly increased leucocyte counts in males and females at 100 mg/kg bw/day, primarily due to increased neutrophil counts, were observed. Increased leucocyte counts were also reported for females at 30 mg/kg bw/day, whereas the percentage of neutrophils was increased in both sexes at this dose level. Spleen weights were moderately increased in both sexes at 100 mg/kg bw/day. In correlation, enlarged spleen was observed in one male and 4 females at 100 mg/kg bw/day. Enlarged mesenteric lymph nodes were present in 5 males and all females at 100 mg/kg bw/day, in 6 females at 30 mg/kg bw/day and in 2 females at 10 mg/kg bw/day. Histopathological lesions in the mesenteric lymph nodes (foamy macrophages with/without fibrosis, sinus ectasia, focal necrosis within the aggregates of foamy macrophages with/without fibrosis and macrophage foci) and adrenal cortex (inflammatory lymphocytic cells) were noted in males and females, respectively, and were considered to be treatment-related. Since these effects were observed in both sexes of all dose groups, the LOAEL was set at the lowest dose level of 10 mg/kg bw/day.
The available data from the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD 422 conducted with the analogue substance Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates (CAS 80939-62-4) are insufficient for the purpose of classification under Regulation (EC) No.1272/2008.Therefore, a 90d repeated dose toxicity is proposed. Based on the data of this subchronic study a decision on the classification under Regulation (EC) No.1272/2008 will be made.
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