Registration Dossier
Registration Dossier
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EC number: 939-690-1 | CAS number: -
Toxicological information
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Dec 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- scarified skin was also tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- scarified skin was also tested
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- EC Number:
- 230-743-8
- EC Name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- Cas Number:
- 7299-99-2
- Molecular formula:
- C37H68O8
- IUPAC Name:
- 3-[(2-ethylhexanoyl)oxy]-2,2-bis{[(2-ethylhexanoyl)oxy]methyl}propyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): Tetraoctanoate de Pentaerythritol
- Analytical purity: not reported
- Storage condition of test material: room temperature in sterile bottle
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CARON-St GermainLaxis, 77950 Maincy, France
- Sex: male
- Weight at study initiation: about 2.5 - 3 kg
- Housing: in individual polysterene cages of standardized dimensions with perforated floor
- Diet: ALIMENT EXTRALABO C15 Ets Pietrement (77482 Provins), ad libitum
- Water: tap water provided in sterilized makrolon bottles equipped with stainless steel pipettes, ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 50 - 80
- Air changes (per hr): 3000 m³
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 4, 24, 48 and 72 h and 4 and 7 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: left side (intact) and right side (scarified9) of the animal
- Site preparation: before the test, the skin sites were shaved with shears in order to cover a surface of about 14x14 cm. While the left side was intact, three parallel scarifications about 2.5 cm long were created on the right site.
- Type of wrap if used: sterile gauze patch (2.5x2.5 cm) held in place by adhesive strips (10 cm wide; Urgocrepe Fournier)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any trace of substance was eliminated with distilled water or, if necessary, with 5% SDS solution followed by careful rinsing
- Time after start of exposure: 4 h
SCORING SYSTEM:
Acc. to method outlined in the Official French Gazette of 21 Feb 1982, Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- While one animal showed an slight edema reaction on the intact and scarified skin 4 hours after application, another animal had a slight edema reaction on the intact skin 24 h after application. From 48 h on, all animals showed no skin reactions.
Any other information on results incl. tables
Results:
| Time | Animal | Intact skin | ||||
| Erythema | Edema | Necrosis | Corrosion | Desquamation | ||
| 4 h | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 0 | 0 | 0 | 0 | |
| 1072 | 0 | 1 | 0 | 0 | 0 | |
| 24 h | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 1 | 0 | 0 | 0 | |
| 1072 | 0 | 0 | 0 | 0 | 0 | |
| 48 h | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 0 | 0 | 0 | 0 | |
| 1072 | 0 | 0 | 0 | 0 | 0 | |
| 72 h | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 0 | 0 | 0 | 0 | |
| 1072 | 0 | 0 | 0 | 0 | 0 | |
| 4 days | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 0 | 0 | 0 | 0 | |
| 1072 | 0 | 0 | 0 | 0 | 0 | |
| 7 days | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 0 | 0 | 0 | 0 | |
| 1072 | 0 | 0 | 0 | 0 | 0 | |
| mean 24 - 72 h | 1070 | 0 | 0 | 0 | 0 | 0 |
| 1071 | 0 | 0.3 | 0 | 0 | 0 | |
| 1072 | 0 | 0 | 0 | 0 | 0 | |
| mean | 0 | 0.1 | ||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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