Registration Dossier
Registration Dossier
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EC number: 209-967-5 | CAS number: 599-61-1
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: review article published, no GLP, but peer-review
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Type of study / information:
- Toxicity of Dapsone : Summary
Test guideline
- Guideline:
- other: none
- Principles of method if other than guideline:
- Review Article, no methods described
- GLP compliance:
- no
Test material
- Reference substance name:
- Dapsone
- EC Number:
- 201-248-4
- EC Name:
- Dapsone
- Cas Number:
- 80-08-0
- Molecular formula:
- C12H12N2O2S
- IUPAC Name:
- 4,4'-sulfonyldianiline
- Details on test material:
- Dapsone, pharmaceutical grade
Constituent 1
Results and discussion
Any other information on results incl. tables
Effects observed:
Red Cell toxicity: Methemoglobinaemia, Heinz body haemolytic anemia formation
WBC toxicity: Leukopenia, Agranulocytosis, "Pseudoleukemia"
Sulfone syndrome, Infectious mononucleosis-like syndrome
Skin manifestations: Hyperpigmentation macula, morbiliform rash, Urticaria, phototoxicity, toxic epidermal necrolysis, lupus erythematosus syndrome
GI manifestations: Anorexia, colic, nausea, vomiting, hepatitis, cholestatic jaundice
Neurologic manifestations: Psychosis, peripheral neuropathy, headache, dizziness, blurred vision, timmitus
Lepra reaction, fever, nephrotic syndrome
Methemoglobinaemia is probably induced by the 4,4 -DDS metabolite N-hydroxyl derivative of 4,4 -DDS.
In general,, doses of dapsone less than 300 mg per day to normal adults are associated with minimal side effectes which are manageable.
Applicant's summary and conclusion
- Conclusions:
- Dapsone can induce a large variety of symptoms and sydromes in patients at a dose of 100 mg/person/day , which is the "normal" dose applied world-wide. However, these side-effects are reversible upon cessation of treatment or be using appropriate counter-pharmaceuticals.
- Executive summary:
Dapsone can induce a large variety of symptoms and sydromes in patients at a dose of 100 mg/person/day , which is the"normal" dose applied world-wide. However, these side-effects are reversible upon cessation of treatment or be using appropriate counter-pharmaceuticals. The side-effects at the dose of 100 mg/person/day are generally not life-threatening ; only rare patients with an abnormal disposition may show severe effects.
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