Registration Dossier
Registration Dossier
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EC number: 203-529-7 | CAS number: 107-88-0
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1949
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 949
- Report date:
- 1949
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- acute and repeated dermal irritation test
- GLP compliance:
- no
Test material
- Reference substance name:
- Butane-1,3-diol
- EC Number:
- 203-529-7
- EC Name:
- Butane-1,3-diol
- Cas Number:
- 107-88-0
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,3-diol
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): 1,3-Butylenglykol, purity not stated
Constituent 1
Method
- Type of population:
- general
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Details on exposure:
- Volunteers were exposed to neat substance either at the intact upper arm and fore arm skin (single exposure: dose, occlusion and duration not stated, repeated exposure: 16 days, every other day, 5 g on 9 cm2, occluded for 24 h) or at the oral mucosa (dose and duration not stated).
Results and discussion
- Results of examinations:
- No signs of irritation were oberved at the skin or mouth mucosa in these test protocols.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test substance was not irritating to skin or mouth mucosa.
- Executive summary:
Volunteers were exposed to neat test substance either at the intact upper arm and fore arm skin (single exposure: dose, occlusion and duration not stated, repeated exposure: 16 days, every other day, 5 g on 9 cm2, occluded for 24 h) or at the oral mucosa (dose and duration not stated). No signs of irritation were observed (Fischer et al., 1949; Loeser, 1949).
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