Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 294-590-9 | CAS number: 91744-28-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 25 - 28 May 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. No details on analytical purity of the substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- no details on analytical purity of the substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C12-18
- EC Number:
- 266-944-2
- EC Name:
- Glycerides, C12-18
- Cas Number:
- 67701-26-2
- Molecular formula:
- C39H74O6 to C57H110O6
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.24-2.64 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet (Preston Farmers Ltd., Lincolnshire, UK), ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-20
- Humidity (%): 68-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved
- 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
The test material was warmed to approx. 40 ºC and applied as a liquid to the skin. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank area
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, surgical adhesive tap, elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 1 h post-application: slight erythema was observed in 1/6 animals.
24 h post-application: slight erythema was observed in 1/6 animals.
48 h post-application: slight erythema was observed in 3/6 animals. In one of these animals, the reaction extended up to 4 cm beyond the treatment site.
72 h post-application: no skin reactions were noted.
No edema was observed in any animal at any reading time point. - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table1 . Results of skin irritation study.
| Observation time | Rabbit no. | |||||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | |||||||
| Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
| 1 h | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 24 h | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 48 h | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| 72 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mean value 24 + 48 + 72 h | 0.33 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.67 | 0.00 | 0.00 | 0.00 | 0.33 | 0.00 |
| Mean value 24 + 48 + 72 h all animals | 0.22 | 0.00 | ||||||||||
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
