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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-291-1 | CAS number: 7011-83-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1984-09-25 to 1984-10-26
- 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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- The deviation was that the test substance was tested as a dilution and therefore not sufficient for hazard assessment.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-hexyldihydro-5-methylfuran-2(3H)-one
- EC Number:
- 230-291-1
- EC Name:
- 5-hexyldihydro-5-methylfuran-2(3H)-one
- Cas Number:
- 7011-83-8
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 5-hexyldihydro-5-methylfuran-2(3H)-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.19-2.51 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum, Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire
- Water: ad libitum, tap water
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 ± 1.5
- Humidity (%): 65-68
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: liquid paraffin
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (100 %) and 75 % for 1 animal in range finding test; 50, 25 and 10 % for 1 animal in range finding test; main study 25 % were used. - Duration of treatment / exposure:
- Range finding test: 24 h
Main study: 4, 12 and 24 h - Observation period:
- 72 h
Observations done at 1, 24, 48 and 72 h after removal - Number of animals:
- Range finding test: 2 (sex not specified)
Main study: 3 (sex not specified) - Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap: surgical gauze two layers thick secured with a cross of Sleek adhesive strapping, in addition elasticated corset (Tubigrip)
REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in lukewarm water
- Time after start of exposure: immediately after 24 h (Range finding test) or 4 h (main study) treatment
SCORING SYSTEM: Draize J.H. (1959)1959), Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" Details on scouring system see "Any other information"
Interpretation of Results:
For each test material concentration the scores for erythema and oedema at the 24 and 72 hour readings were totaled for the three test rabbits (12 values). This total was divided by 6 to give the Primary Cutaneous Irritation Index of each of the four concentrations. This index was used to classify the skin irritation properties of each test material concentration according to the following scheme (after Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics")
Details on Primary Cutaneous Irritation Index interpretation see "Any other information"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 12 h exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 24 h exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 12 h exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 24 h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25 %, 4 h exposure
Any other information on results incl. tables
Range finding test
| Animal | Concentration [%] | Timepoint [h] | Erythema score (of max. 4) | Edema score (of max. 4) |
| 1 | 100 | 1 | 1.00 | 0 |
| 75 | 1 | 1.00 | 0 | |
| Control | 1 | 0 | 0 | |
| 2 | 50 | 1 | 1.00 | 0 |
| 25 | 1 | 0.00 | 0 | |
| 10 | 1 | 0.00 | 0 | |
| Control | 1 | 0 | 0 |
Mean scores
| 25 % with an exposure time of [h] | Mean Erythema score (24/48/72 h) | Mean Edema score (24/48/72 h) |
| 4 | 0.00 | 0.00 |
| 12 | 0.00 | 0.00 |
| 24 | 0.00 | 0.00 |
| Vehicle only: 24 | 0.00 | 0.00 |
Individual scores
| Animal | 25 % with an exposure time of [h] | Timepoint [h] | Erythema score (of max. 4) | Edema score (of max. 4) |
| 1 | 4 | 1 | 0.00 | 0 |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 12 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 24 | 24 | 0.00 | 0 | |
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| Vehicle only: 24 | 24 | 0.00 | 0 | |
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 2 | 4 | 1 | 0.00 | 0 |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 12 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 24 | 24 | 0.00 | 0 | |
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| Vehicle only: 24 | 24 | 0.00 | 0 | |
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 3 | 4 | 1 | 0.00 | 0 |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 12 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 24 | 24 | 0.00 | 0 | |
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| Vehicle only: 24 | 24 | 0.00 | 0 | |
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study to determine the skin irritation potential of the test substance in rabbits was conducted and a non-irritating effect at a concentration of 25 % was established.
- Executive summary:
A skin irritation test was performed. A range finding test with 2 animals was conducted. The exposure time was 24 h and concentrations 100, 75, 50, 25 and 5 or 10 % were applied. The range finding test revealed a very slight erythema reaction to concentrations of 100, 75 and 50 % test substance. The main study was conducted using 3 rabbits with the highest non irritating concentration from the range finding test of 25 % and exposure times of 4, 12 and 24 hours. The animals were observed for 72 hours. The mean erythema and edema score for 24/48/72h were 0 for all exposure times. The erythema and the edema score for animal 1 for 24/48/72h with 25 % test substance was 0 for all exposure durations. The erythema and the edema score for animal 2 for 24/48/72h with 25 % test substance was 0 for all exposure durations. The erythema and the edema score for animal 3 for 24/48/72h with 25 % test substance was 0 for all exposure durations. Due to these results the test substance was found to be not skin irritating and without classification at 25 %.
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.
