Registration Dossier
Registration Dossier
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EC number: 203-953-2 | CAS number: 112-27-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- secondary source
- Title:
- Toxicology Update: Triethylene glycol.
- Author:
- Ballantyne, B., Snellings, W.M.
- Year:
- 2 007
- Bibliographic source:
- J. Appl. Toxicol. 27, 291 - 299
Materials and methods
- Principles of method if other than guideline:
- Six New Zealand White rabbits were dosed with 0.5 mL of test material under an occlusive dressing for a period of 4 hours. After the exposure period skin reactions were scored via the method of Draize.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-(ethylenedioxy)diethanol
- EC Number:
- 203-953-2
- EC Name:
- 2,2'-(ethylenedioxy)diethanol
- Cas Number:
- 112-27-6
- Molecular formula:
- C6H14O4
- IUPAC Name:
- 2-[2-(2-hydroxyethoxy)ethoxy]ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Batch no.: TS-3200424
- Appearance: Colorless, transparent viscous liquid
- Purity: 99.82%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- Male and female animals are dosed with 0.5 mL. The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material is applied to each of 6 rabbits, which are restrained for the 4 h contact period. Excess sample is removed after contact. Skin reaction is scored by the method of Draize at 1 hour, 1 day, 2 days, 3 days and 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No erythema or eschar formation, no edema formation. Other irritation or effects: none.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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