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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: dermal
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
To assess the acute dermal toxicity of 2-(2,5-diaminophenyl)ethanol sulphate (3-(2-hydroxyethyl)-p-phenylenediammonium sulphate) extrapolation calculations were performed.
GLP compliance:
no
Test type:
other: extrapolation calculation
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(2-hydroxyethyl)-p-phenylenediammonium sulphate
EC Number:
298-995-1
EC Name:
3-(2-hydroxyethyl)-p-phenylenediammonium sulphate
Cas Number:
93841-25-9
Molecular formula:
C8H12N2O.H2O4S
IUPAC Name:
2-(2,5-Diaminophenyl)ethanol sulfate (1:1)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
14 032 mg/kg bw
Based on:
other: kinetic based calculation

Any other information on results incl. tables

LD50/oral/rat : 80 mg/kg bw

Oral bioavailability : 100% using data from the toxicokinetic study in Sprague-Dawley rats

Dermal bioavailability : 0.57% as detailed in SCCS opinion on hydroxyethyl-p-phenylenediamine sulfate (SCCS/1310/10)

Calculation

Determination of the correction factor oral vs dermal route : 100% oral vs 0.57% dermal

= 100/0.57 = 175.4

LD50 calc dermal = 80 x 175.4 = 14032 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the available acute oral toxicity and kinetic data, the LD50 value for acute dermal toxicity of 2-(2,5-diaminophenyl)ethanol sulphate (3-(2-hydroxyethyl)-p-phenylenediammonium sulphate) was calculated to be 14032 mg/kg bw. The substance is not classified according to CLP (GHS) criteria.
Executive summary:

The determination of acute dermal toxicity was performed by calculation using the available acute oral toxicity and kinetic data. The bioavailability of 2-(2,5-diaminophenyl)ethanol sulphate (3-(2-hydroxyethyl)-p-phenylenediammonium sulphate) via the dermal route is very low compared to the oral bioavailability of the substance. The LD50 value for acute dermal toxicity of 2-(2,5-diaminophenyl)ethanol sulphate (3-(2-hydroxyethyl)-p-phenylenediammonium sulphate) was calculated to be 14032 mg/kg bw. The approach to determine dermal toxicity using oral data is accepted by EU regulatory agencies. The substance is not classified according to CLP (GHS) criteria.