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EC number: 202-319-2 | CAS number: 94-28-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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 (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
- EC Number:
- 202-319-2
- EC Name:
- 2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
- Cas Number:
- 94-28-0
- Molecular formula:
- C22H42O6
- IUPAC Name:
- 2-(2-{2-[(2-ethylhexanoyl)oxy]ethoxy}ethoxy)ethyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): Eastman TEG-EH
- Description: Eastman(TM) TEG-EH (Triethylene Glycol Bis (2-EthylHexanoate)) Plasticizer
- Physical state: clear colourless liquid
- Specific gravity: 0,968 (20/20C)
- Analytical purity: 99,1% (ester by GC)
- Impurities (identity and concentrations): see confidential details on test material
- Composition of test material, percentage of components: see confidential details on test material
- Purity test date: 2007-07-11
- Lot/batch No.: TD-7022702
- Expiration date of the lot/batch : not provided (production date = 2007-07-11)
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum (Certified Rabbit diet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Relative humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES: From: 2007-08-01 To 2007-08-08
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- single 4-hour exposure period
- Observation period:
- After approximately one hour following removal of the patches and 24, 48 and 72 hours later.
An additional observation was made on Day 7 to assess the reversibility of skin reactions. - Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 4-hour
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 66480 Male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66480 Male
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66480 Male
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66491 Male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66491 Male
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66491 Male
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66492 Male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66492 Male
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 66492 Male
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 66480 Male
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66480 Male
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66480 Male
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66491 Male
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66491 Male
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66491 Male
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66492 Male
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66492 Male
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 66492 Male
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight erythema was noted at all treated skin sites at the 24 and 48-hour observations and at one treated skin site at the 72-hour observation.
Two treated skin sites appeared normal at the 72-hour observation and the remaining treated skin site appeared normal at the 7-day observation.
Any other information on results incl. tables
Individual skin reactions:
Skin reaction |
Observation time |
Individual Scores – Rabbit Number and sex |
Total |
||
66480 Male |
66491 Male |
66492 Male |
|||
Erythema/Eschar formation |
1 hour |
0 |
0 |
0 |
0 |
24 hours |
1 |
1 |
1 |
3 |
|
48 hours |
1 |
1 |
1 |
3 |
|
72 hours |
0 |
0 |
1 |
1 |
|
7 days |
0 |
0 |
0 |
0 |
|
Oedema formation |
1 hour |
0 |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-hour readings (S): 4 |
|||||
Primary Irritation Index (S/6): 4/6 = 0.7 |
|||||
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize classification criteria, 1959
- Conclusions:
- Mild irritant
- Executive summary:
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. Two treated skin sites appeared normal at the 72-hour observation and the remaining treated skin site appeared normal at the 7-day observation. The test material produced a primary irritation index of 0.7 and was classified as mild irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.
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