(p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Study period:

February

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

The calculation of acute toxicity values for N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is based on the current understanding and knowledge of the test substance.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

For the determination of the acute dermal toxicity, the bioavailability after topical application was used. Since there were no in vivo toxicokinetics studies conducted for the dermal route, this was predicted using scientifically accepted equations to derive the absorbed amount of an infinite dose of N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE. The bioavailability via the dermal route was predicted to be lower (15% of the applied dose) than the oral bioavailability of N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE, and it was in line with that of a structurally similar chemical (A160). The resulting LD50 for dermal toxicity (LD50 calc dermal) was calculated.

GLP compliance:

no

Remarks:

Not required

Test type:

other: extrapolation calculation

Test material

Test material information

Constituent 1

Reference substance name:

(p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate

EC Number:

259-134-5

EC Name:

(p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate

Cas Number:

54381-16-7

Molecular formula:

C10H16N2O2.H2O4S

IUPAC Name:

(p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate

Test material form:

solid: particulate/powder

Remarks:

light grey powder

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

428 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Calculation:

Determination of the correction factor oral vs. dermal route:

60% oral vs. 15% dermal = 4.0 (60 / 15 = 4.0)

Determination of the LD50 calc dermal for the sulfate salt:

107 mg/kg bw x 4.0 = 428 mg/kg bw Equation 10

Result:

LD50 calc dermal 2 N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE = 428 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The calculated LD50 value for the dermal toxicity of N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE is 428 mg/kg bw. Therefore, it should be classified as Acute Tox Cat.3; H311: “Toxic in contact with skin”, according to the CLP criteria.

Executive summary:

For the determination of the acute dermal toxicity, the bioavailability after topical application was used. Since there were no in vivo toxicokinetics studies conducted for the dermal route, this was predicted using scientifically accepted equations to derive the absorbed amount of an infinite dose of N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE. The bioavailability via the dermal route was predicted to be lower (15% of the applied dose) than the oral bioavailability of N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE, and it was in line with that of a structurally similar chemical (A160).

The resulting LD50 for dermal toxicity (LD50 calc dermal) was calculated to be 428 mg/kg bw. The approach to determine dermal toxicity using oral data is accepted by the German and EU regulatory agencies.

Based on these data, N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE should be classified as Acute Tox Cat.3; H302: “Toxic if swallowed”, according to the CLP criteria.