Registration Dossier
Registration Dossier
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EC number: 200-860-9 | CAS number: 75-31-0
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- absorption
- bioaccessibility (or bioavailability)
- toxicokinetics
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isopropylamine
- EC Number:
- 200-860-9
- EC Name:
- Isopropylamine
- Cas Number:
- 75-31-0
- Molecular formula:
- C3H9N
- IUPAC Name:
- propan-2-amine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- other: human skin in vitro
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Freshly excised human skin was exposed to 3000 ppm isopropylamine vapour for up to 30 min in static Franz diffusion cells
- Duration and frequency of treatment / exposure:
- 20 and 30 min
Doses / concentrations
- Dose / conc.:
- 3 000 ppm
- Details on study design:
- skin absorption and skin penetration was measured, as well as the effect of covering the skin patches with denim and 30 min ventilation of the skin with fresh air post exposure
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- There is low absorption and penetration of isopropanol of human skin in vitro
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Skin absorption (in µg):
20 min: bare skin: 4.4 (± 2.8)
30 min: bare skin: 11 (±3.8), ventilated skin: 2.2 (±1.7), skin covered with denim: 1.6 (±0.24)
Skin penetration (in µg):
20 min: bare skin: <0.10
30 min: bare skin: 0.12 (±0.02), ventilated skin: 0.31 (±0.10), skin covered with denim: <0.10
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test substance penetrated human skin only to a small extent.
- Executive summary:
Freshly excised human skin was exposed to 3000 ppm isopropylamine vapour for up to 30 min in static Franz diffusion cells. Absorption and penetration to bare skin, skin ventilated for 30 min after exposure and skin covered with denim was measured after 20 and 30 min. Only low absorption and penetration was observed, which was further reduced by ventilation and covering with denim.
The measured values were:
Skin absorption (in µg):
20 min: bare skin: 4.4 (± 2.8)
30 min: bare skin: 11 (±3.8), ventilated skin: 2.2 (±1.7), skin covered with denim: 1.6 (±0.24)
Skin penetration (in µg):
20 min: bare skin: <0.10
30 min: bare skin: 0.12 (±0.02), ventilated skin: 0.31 (±0.10), skin covered with denim: <0.10
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