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Administrative data

Endpoint:
acute toxicity: inhalation
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 inhalation 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:
3-(2-hydroxyethyl)-p-phenylenediammonium sulphate

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
1.13 mg/L air
Based on:
other: extrapolation calculation
Exp. duration:
4 h

Any other information on results incl. tables

Calculations :

Maximum volume of exposure in 4 hours :

0.074 L/min x 60 min x 4 hour = 17.76 litres

Maximum achievable exposure regarding required 5 mg/L for 4 hours (OECD 403)

17.76 x 5 mg/L = 88.8 mg/rat

88.8 mg/0.25kg bw = 355 mg/kg maximum achievable exposure

Inhalation bioavailability : 100% (assumed)

Correction factor oral vsinhalation route : 1.00

LC50 calc inhalation = 80 x 0.25 x 1.00/17.76 = 1.13 mg/L

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the available acute oral toxicity and kinetic data, the LD50 value for acute inhalation toxicity of 2-(2,5-diaminophenyl)ethanol sulphate (3-(2-hydroxyethyl)-p-phenylenediammonium sulphate) was calculated to be 1.13 mg/L. The substance is classified as Acute Tox. Cat 4; H332 harmful if inhaled according to CLP (GHS) criteria.
Executive summary:

The determination of acute inhalation 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 inhalation route is assumed to be 100% (equivalent to oral bioavailability). The LD50 value for acute inhalation toxicity of 2-(2,5-diaminophenyl)ethanol sulphate (3-(2-hydroxyethyl)-p-phenylenediammonium sulphate) was calculated to be 1.13 mg/L.The substance is classified as Acute Tox. Cat 4; H332 harmful if inhaled according to CLP (GHS) criteria.

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