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EC number: 205-465-5 | CAS number: 141-17-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 Nov 1997 - 11 Nov 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- secondary source
- Title:
- EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester
- Author:
- US EPA
- Year:
- 2 011
- Bibliographic source:
- High Production Volume Chemical Challenge Program
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- EC Number:
- 205-465-5
- EC Name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- Cas Number:
- 141-17-3
- Molecular formula:
- C22H42O8
- IUPAC Name:
- bis(2-(2-butoxyethoxy)ethyl) adipate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Davidson Mill Breeding Laboratories, Jamesburg, New Jersey, USA- Age at arrival: 3 months- Fasting period before study: none- Housing: stainless steel cages- Diet: Lab Diet Certified Rabbit Diet #5322, ad libitum- Water: ad libitum- Acclimation period: 13 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 4 Nov 1997 to 11 Nov 1997
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days Reading time points: 4.5, 24, 48, and 72 h and 7 days after treatment)
- Number of animals:
- 6 (3 males, 3 females)
- Details on study design:
- TEST SITE- Area of exposure: approximately 6 cm²- Type of wrap if used: The area was covered with a 2.5 cm² surgical gauze pad (Johnson & Johnson). This was held in place with 3 inch Johnson & Johnson hypo-allergenic cloth tape, semi-occlusively. Animals were collared for the deration of the exposure to preclude access to the siteREMOVAL OF TEST SUBSTANCE- Washing (if done): Remaining test article was gently washed from the skin with water and paper towels.- Time after start of exposure: 4 hSCORING SYSTEM: Each site was then individually examined and scored at 30 and 60 minutes following unwrapping for erythema and edema according to the Draize Scoring System.OTHERThe hair of the mid-dorsal area of the trunk of each animal, between scapulae and pelvis, was shaved using an Oster small animal clipper with surgical head (#40). Care was taken to avoid abrasion of the skin during clipping. Prior to dose application, animals were placed into wooden restrainers.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: One animal showed accumulation of loose fragments of horny layer of skin (stratum corneum). Peeling. Only uppermost layer involved.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: revrsibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- The animals did not exhibit any abnormal clinical signs for the duration of the study.
Any other information on results incl. tables
Table 1: Primary dermal irritation in rabbits / individual results
Rabbit (number) |
4 ½ hr |
24 hr |
48 hr |
72 hr |
Day 7 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
- |
- |
2 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
3 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
- |
- |
4 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
5 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0* |
6 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
* Accumulation of loose fragments of horny layer of skin (stratum corneum). Peeling. Only uppermost layer involved.
The primary dermal irritation index was 0.65. The animals in this study did not exhibit any abnormal signs for the duration of the study. Under the conditions of this study, the test article elicited minimal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
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