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Registration Dossier
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EC number: 285-550-1 | CAS number: 85116-97-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given (no details on test substance and test design (type of coverage, exposure duration))
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- yes
- Remarks:
- (no details on test substance and test design (type of coverage, exposure duration))
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fatty acids, C16-18, esters with diethylene glycol
- EC Number:
- 285-550-1
- EC Name:
- Fatty acids, C16-18, esters with diethylene glycol
- Cas Number:
- 85116-97-8
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Fatty acids, C16-18, esters with diethylene glycol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Duration of treatment / exposure:
- no data
- Observation period:
- 5 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Very slight erythema (graded with score 1) were observed in all test animals starting 1 h after patch removal which were stable up to the 72 h reading time point. Moreover, slight edema (scored with 2) were determined in 1/3 animals 1 h after application which was still visible as very slight edema (score 1) up to the 72 h reading time point. The remaining animals revealed very slight edema (score 1) at the 1 h reading time point which were reversible 24 h later. Latest on Day 5 after test substance application, the skin reactions were fully reversible.
Any other information on results incl. tables
Table 1. Individual skin reaction scores
| Observation time | Rabbit no. | |||||
| 1 | 2 | 3 | ||||
| Erythema | Edema | Erythema | Edema | Erythema | Edema | |
| 1 h | 1 | 2 | 1 | 1 | 1 | 1 |
| 24 h | 1 | 1 | 1 | 0 | 1 | 0 |
| 48 h | 1 | 1 | 1 | 0 | 1 | 0 |
| 72 h | 1 | 1 | 1 | 0 | 1 | 0 |
| Mean value 24 + 48 + 72 h | 1,00 | 1,00 | 1,00 | 0,00 | 1,00 | 0,00 |
| Mean value 24 + 48 + 72 h all animals | 1,00 | 0,33 | ||||
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
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