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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.