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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

Effects on developmental toxicity

Description of key information
The test item, 2,4-diaminophenoxyethanol dihydrochloride, administered daily by gavage to pregnant female Sprague-Dawley rats from days 6 to 19 of gestation was well tolerated at 4 and 20 mg/kg bw/day. At 125 mg/kg bw/day, 11/24 females presented excessive salivation. The maternal body weight gain and food consumption were significantly lower throughout the dosing period. A slightly significantly lower fetal weight was observed at this dose-level, associated with a slightly higher number of fetuses with incomplete ossification of thoracic vertebra centrum and an increased incidence of short supernumerary 14th ribs. Under these experimental conditions, the NOEL for maternal toxicity and embryofetal development are 20 mg/kg bw/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
20 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The objective of this prenatal developmental toxicity study was to evaluate the potential toxic effects of the test item 2,4 -diaminophenoxyethanol dihydrochloride on the pregnant female and on embryonic and fetal development following daily oral administration (gavage) to pregnant female rats from implantation to the day prior to scheduled hysterectomy (day 6 to day 19 of gestation inclusive).

Three groups of 24 mated female rats of the Sprague-Dawley strain received the test item at 4, 20 or 125 mg/kg bw/day. Another group of 24 females acted as a control group and received the vehicle, purified water, under the same experimental conditions. Clinical signs and mortality were checked daily. Body weight and food consumption were recorded at designated intervals. On day 20 of gestation, the dams were sacrificed and subjected to a macroscopic examination. The gravid uterus was weighed and then the fetuses were removed. The numbers of corpora lutea, implantation sites, early and late resorptions and dead and live fetuses were recorded. The fetuses were weighed, sexed and subjected to external, visceral or skeletal examinations.

At 125 mg/kg bw/day, excessive salivation was transiently observed in 11/24 females. Body weight gain was statistically significantly reduced throughout the dosing period resulting in an overall reduction of 24% during the dosing period (days 6 to 20 post coitum), when compared to controls. The group mean food consumption was statistically significantly reduced throughout the dosing period when compared to controls. There was a statistically significant reduction in the mean fetal weight (-7%,) associated with a statistically significantly increased incidence of fetuses showing incomplete ossification of thoracic vertebra centrum or supernumerary short 14th rib. At 4 and 20 mg/kg bw/day, there was no maternal toxicity and no effects on the embryo-fetal development.

The test item, 2,4-diaminophenoxyethanol dihydrochloride, administered daily by gavage to pregnant female Sprague-Dawley rats from days 6 to 19 of gestation was well tolerated at 4 and 20 mg/kg bw/day. At 125 mg/kg bw/day, 11/24 females presented excessive salivation. The maternal body weight gain and food consumption were significantly lower throughout the dosing period. A slightly significantly lower fetal weight was observed at this dose-level, associated with a slightly higher number of fetuses with incomplete ossification of thoracic vertebra centrum and an increased incidence of short supernumerary 14th ribs. Under these experimental conditions, the NOEL for maternal toxicity and embryofetal development are 20 mg/kg bw/day.

Justification for classification or non-classification

Additional information