Registration Dossier
Registration Dossier
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EC number: 298-995-1 | CAS number: 93841-25-9
Acute Toxicity: dermal
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:
- 2 020
- 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
- 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)
Constituent 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.
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