Registration Dossier
Registration Dossier
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EC number: 204-001-9 | CAS number: 112-73-2
Endpoint summary
Administrative data
Description of key information
DEGDBE is not skin irritating and not eye irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-02-04 to 2002-03-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed; Guideliine study; GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amoung applied: 0.5 ml Diethylenegylkoldibutylether
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1d,2d,3d
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1d,2d,3d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1d,2d,3d
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1d,2d,3d
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1d,2d,3d
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1d,2d,3d
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DEGDBE was tested for its skin irritation potential according to the OECD Guideline 404. No classification is warranted.
- Executive summary:
DEGDBE was tested for its skin irritaiton potential according to the OECD Guideline 404.
24 hours up to 7 days after removal of the plaster the animals showed very slight up to well-defined erythema and 48 hours up to 7 days very slight up to well-defined oedema. Additionally, the skin surface of all animals was dry-rought, and of one animal was coarse scaled, too. 14 days after adiministration all signs of irritation were reversible.
Based on the obtained result, DEGDBE is not skin irritating.
Reference
Observations:
24 hours up to 7 days after removal of the plaster the animals showed very slight up to well-defined erythema and 48 hours up to 7 days very slight up to well-defined oedema. Additionally, the skin surface of all animals was dry-rought, and of one animal was coarse scaled, too. 14 days after adiministration all signs of irritation were reversible.
Individual Scores
| Animal | Reading Time | Erythema | Oedema |
| Animal #1 | 1h | 0 | 0 |
| 1d | 1 | 0 | |
| 2d | 2 | 1 | |
| 3d | 2 | 2 | |
| 7d | 2 | 1 | |
| 14d | 0 | 0 | |
| Animal #2 | 1h | 0 | 0 |
| 1d | 0 | 0 | |
| 2d | 0 | 0 | |
| 3d | 1 | 2 | |
| 7d | 1 | 2 | |
| 14d | 0 | 0 | |
| Animal #3 | 1h | 0 | 0 |
| 1d | 1 | 0 | |
| 2d | 2 | 0 | |
| 3d | 2 | 2 | |
| 7d | 2 | 1 | |
| 14d | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-02-06 to 2002-04-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed study; Guideline study; GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1d,2d,3d
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DEGDBE was investigated for its eye irritation potential according to OECD 405. DEGDBE is not irritating to eyes.
- Executive summary:
DEGDBE was investigated for its eye irritation potential according to OECD 405.
One hour after administration the conjuctivae of all animals showed definitely injected blood vessels. Furthermore, one animal showed definitely injected blood vessels up to a crimson red color and slight swellings 24 hours up to 72 hours after adiminstration. Diffuse areas of opacity of the cornea were observed 24 hours after adiminstration. In the fluoresceine test 24 hours after administration staining areas were observe in this animal. In addition ot these observations, clear-colorless serous eye discharge was noted in all animals. 7 days after administration all signs of irriation had disappeared.
DEGDBE is not irritating to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Scientifically well performed study; Guideline study; GLP study
Justification for selection of eye irritation endpoint:
Scientifically well performed study; Guideline study; GLP study
Justification for classification or non-classification
The skin and eye irritation potential of DEGDBE was investigated according to OECD Guideline 404 and 405 respectively. Based on the results of these studies, no classificaiton is warranted.
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