Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. 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 NOAEL for maternal toxicity and embryofetal development are 20 mg/kg bw/day. A NOAEL of 25 mg/kg bw/day is calculated for 2,4 -diaminophenoxyethanol sulphate. 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
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

Justification for classification or non-classification

Additional information