Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 234-398-4 | CAS number: 11140-04-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 18th - March 25th, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Purity of test substance not given.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octanoic acid, ester with 1,2,3-propanetriol
- EC Number:
- 234-398-4
- EC Name:
- Octanoic acid, ester with 1,2,3-propanetriol
- Cas Number:
- 11140-04-8
- Molecular formula:
- C8H16O2.xC3H8O3
- IUPAC Name:
- Octanoic acid, ester with 1,2,3-propanetriol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Imwitor 908
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, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.54 - 3.40 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 19
- Humidity (%): 45 - 48
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 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 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- 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
After exposure period of 4 h any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test material, octanoic acid, ester with 1,2,3 -propanetriol, was found to be a mild irritant to rabbit skin.
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.
