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EC number: 245-509-0 | CAS number: 23235-61-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June 1995 - 30 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed to GLP and according to appropriate OECD and EC test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- EC Number:
- 245-509-0
- EC Name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- Cas Number:
- 23235-61-2
- Molecular formula:
- C12H26O5
- IUPAC Name:
- 2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): Di-TMP (flakes), Di-Trimethylolpropane
- Physical state: Irregular white crystalline flakes.
- Lot/batch No.: 54001-80
- Storage condition of test material: Kept in a tight-fitting container at room temperature in the dark
- Other: Test article characterisation (purtiy, solubility and stability etc.) was the responsibility of the Sponsor.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mol:Russian stock from Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.1 - 2.5 kg.
- Housing: Animals caged individually in PPO/HIPS (Noryl) cages (floor area 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): Ad libitum access to pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted.
- Water (e.g. ad libitum): Ad libitum access to domestic quality drinking water, acidified to pH 2.5 with hydrochloric acid to prevent microbial growth.
- Acclimation period: At least one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3ºC
- Humidity (%): 55±15%
- Air changes (per hr): 10 air changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours darkness.
IN-LIFE DATES: From: 19 June 1995 To: 30 June 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g solid test material moistened using 0.5 mL distilled water was applied to 2.5 x 2.5 cm patches. - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- Observations made 1 hour after removal of dressing / test material then 24, 48, and 72 hours after termination of exposure.
- Number of animals:
- 3 female rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: 2 patches, 2.5 x 2.5 cm on each animal.
- Type of wrap if used: gauze patches secured with a semi-occlusive dressing by means of a 1cm wide adhesive tape and fixed with Scanpor tape,
4.5 cm width, loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Patches removed and the skin was washed with lukewarm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scoring system used was consistent with system described in OECD test guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed during the observation period.
- Other effects:
- None
Any other information on results incl. tables
Rabbit No. |
Weight kg |
Test field |
Erythema-Eschar observed at hours* |
Individual mean values |
Oedema observed at hours* |
Individual mean values |
||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|||||
7697 |
2.5 |
L |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
R |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
7700 |
2.1 |
L |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
R |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
7703 |
2.2 |
L |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
R |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Mean of rabbits |
|
|
|
|
|
0.0 |
|
|
|
|
0.0 |
|
Only the scores from the 3 readings (24, 48, and 72 hours) are included in the calculation of the individual mean values.
* after termination of exposure
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DiTMP was found ot be non-irritating to skin, under the conditions of this study and does not require classfication as a skin irritant according to the CLP Regulation.
- Executive summary:
An acute skin irritation study was performed to determine the potential for skin irritation of Di-TMP. The study was conducted to GLP and according to OECD 404 and EC B4 Test Guidelines. No signs of irritation were observed following exposure to the test substance. Di-TMP is not classified as irritating according to CLP.
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