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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

OECD 422 in Sprague Dawley rats, Oral, Gavage

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
good
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

An OECD 422 study using C.I. Solvent Red 175 Solid (solvent stripped) was used to assess effects on general toxicity, neurological and reproductive function, and prenatal/early neonatal growth and survival of offspring in rats following repeated gavage administration. Groups of 12 male and 12 female Crl:CD(SD) rats were administered C.I. Solvent Red 175 Solid (solvent stripped) daily by gavage at dose levels of 0 (control), 100, 300, or 1000 mg/kg/day. Males were dosed for at least four weeks prior to breeding and continuing throughout breeding for a minimum of 48 days. The females were dosed for four weeks prior to breeding, continuing through breeding (up to two weeks), gestation (three weeks), and lactation (thirteen days). Effects on general systemic toxicity, neurobehavioral activity, clinical chemistry, hematology, coagulation, thyroid hormone levels, urine parameters, gonadal function, estrous cyclicity, mating behavior, conception, development of the conceptus, parturition and early postnatal growth and survival of pps were evaluated. In addition, a gross necropsy of the adults was conducted with extensive histopathologic examination of tissues. Litter size, pup survival, sex, body weight, anogenital distance, nipple retention, and gross external morphological alterations were assessed.

Treatment-related clinical observations consisted of red feces in all treated animals and red discolored fur in several treated animals which were attributed to the dye nature of the test material and considered a biomarker of exposure.

There were no treatment-related effects on body weight, body weight gain, feed consumption, neurological or reproductive function, or prenatal neonatal survival, growth, or development of the offspring in any treated groups compared to controls.

Males given 1000 mg/kg/day had a treatment-related increase in mean prothrombin time and mean urea nitrogen concentration that were interpreted to be non-adverse. 

Males and females given 1000 mg/kg/day had treatment-related higher mean absolute and relative liver weights (11.1% and 11.9% higher for males, respectively, and 10.7% and 7.5% higher for females, respectively). No treatment-related change in liver weight was observed in males or females at 100 or 300 mg/kg/day. 

Males given 1000 mg/kg/day had treatment-related slight hypertrophy of periportal hepatocytes and slight necrosis (with or without inflammation) of individual hepatocytes. Females given 1000 mg/kg/day had treatment-related very slight hypertrophy of periportal hepatocytes, very slight vacuolization (consistent with fatty change) of periportal hepatocytes, and very slight necrosis (with or without inflammation) of individual hepatocytes. Males given 300 mg/kg/day had treatment-related very slight hypertrophy of periportal hepatocytes and treatment-related slight necrosis, (with or without inflammation), of individual hepatocytes. No treatment-related liver histopathology was observed at 300 mg/kg/day in females or at 100 mg/kg/day in either sex. 

Based on the presence of treatment-related very slight or slight necrosis of individual hepatocytes in males given 300 or 1000 mg/kg/day and in females given 1000 mg/kg/day, the no-observed adverse effect level (NOAEL) for general toxicity was 100 mg/kg/day for males and 300 mg/kg/day for females. The NOEL for neurological and reproductive toxicity or for effects on prenatal/neonatal growth, survival, and development was 1000 mg/kg/day, the highest dose tested.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No effects observed on reproduction. Criteria for classification and labelling are not met

Additional information