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Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information

According to the key study results (OECD Guideline method 414, GLP compliant, Klimisch 1) and REACh regulation, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Additional information

The key study was conducted following methods comparable to the OECD Guideline 414 (Prenatal Developmental Toxicity Study).

Mated females were assigned randomly to the following treatment groups of 22 females each, test item dose level were used as follows :

Group 1: Vehicle control (bi-distilled water)

Group2: 10 mg/kg bw/day (low dose)

Group 3: 30 mg/kg bw/day (mid dose)

Group 4: 150 mg/kg bw/day (high dose)

The test substance was administered to mated female rats by oral gavage once daily from Days 6 through 20 post-coitum. Control animals were treated with bi-distilled water alone. The female rats were observed daily for clinical signs, abortions and deaths. Body weights were recorded from Day 0 to Day 21 post coitum. Food consumption values were recorded at 3 day-intervals on Days 0-3, 3-6, 6-9, 9-12, 12-15, 15-18 and 18-21 post-coitum. All rats were sacrificed by CO2 asphyxiation on Day 21, and a macroscopic examination was performed. The number of corpora lutea in each ovary was recorded. The uterus of each rat was weighed and examined for pregnancy, number of implantations, live and dead foetuses and early and late resorptions.

Each fetus was identified, weighed and examined for sex and gross external alterations. Approximately half of the fetuses in each litter were examined for soft tissue alterations and the remaining half in each litter examined for skeletal alterations.

In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day.

Justification for classification or non-classification

In this rat teratogenicity key study, reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. According to the key study results (OECD Guideline method 414, GLP compliant, Klimisch 1) and REACh regulation, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate.