Registration Dossier
Registration Dossier
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EC number: 701-466-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Not specified if conducted to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated
- EC Number:
- 500-110-3
- EC Name:
- Propylidynetrimethanol, ethoxylated
- Cas Number:
- 50586-59-9
- Molecular formula:
- C3H5(CH2O(C2H4O)xH) sum of x; >1 - <6.5 mol EO
- IUPAC Name:
- Propylidynetrimethanol, ethoxylated
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Polyol TP30
Trimethylolpropane, ethoxylated, molar ratio 1 :3
purity: > 99%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Buckmsaters, Henham, hertfordshire, England
- Age at study initiation: 12 - 13 weeks
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes after removal of the patch and on days 2,3 and 4.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Shorn Skin, 10 cm square
- Type of wrap if used: Elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 - #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: animal #3: score 1 ca. 30 min. after removal of the dressing
- Irritation parameter:
- edema score
- Basis:
- animal: #1 - #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Not reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of the study do not trigger classification for skin irritation according to the CLP Regulation.
- Executive summary:
The skin irritation of Polyol TP30 (propylidynetrimethanol, ethoxylated) was investigated in a rabbit study (OECD 404). Application of 0.5 mL of the test material for four hours under semi-occlusive conditions to the shorn skin of three rabbits caused minimal transient irritation in one animal. The results of the study do not trigger classification for skin irritation according to the CLP Regulation.
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