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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 26 to April 23, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 404 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted 28 July 2015
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 30-31 January 2017 / Signed on 27 April 2017
Test material
- Reference substance name:
- (±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Cas Number:
- 1352216-65-9
- Molecular formula:
- C13H20O1
- IUPAC Name:
- (±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Reference substance name:
- (±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Cas Number:
- 1352216-63-7
- Molecular formula:
- C13H20O1
- IUPAC Name:
- (±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Test material form:
- liquid
- Details on test material:
- Appearance: Colourless liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Storage: Fridge, light protected, under nitrogen.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Granja San Bernardo (Tulebras, Navarra - Spain)
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2.50-2.78 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff ((ENVIGO - 2030C), ad libitum
- Water: tap-water from public distribution system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: at least 10 cycles per hour.
- Photoperiod: 12 hours light/12 hours dark.
IN-LIFE DATES: From 26 March to 23 April 2019
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch and observations were carrried out from Days 7 to 14 (in case of persistent reactions were observed).
- Number of animals:
- 3 males
- Details on study design:
- PRETEST
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: Undamaged skin area of the right flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were carrried out from Days 7 to 14 (in case of persistent reactions were observed).
SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- A well-defined to moderate erythema was noted on the treated area 1 hour after the patch removal in all animals and was totally reversible between Days 7 and 14.
A moderate oedema was noted on the treated area 1 and 24 hours after the patch removal in all animals and was totally reversible on Day 7.
On the cutaneous structure, dryness of the skin was noted on Day 7 in all animals. The skin recovered a normal aspect on day 14. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure
| Skin reaction | Observation time (following patch removal) | Individual Scores - Rabbit Number and Sex | ||
| A7529 | A7558 | A7559 | ||
| Erythema/Eschar formation | 1 h | 2 | 3 | 3 |
| 24 h | 2 | 3 | 3 | |
| 48 h | 2 | 3 | 3 | |
| 72 h | 2 | 3 | 3 | |
| Day 7 | 1 | 0 | 0 | |
| Day 14 | 0 | 0 | 0 | |
| Total (24, 48 and 72 hours) | 6 | 9 | 9 | |
| Mean (24, 48 and 72 hours) | 2.0 | 3.0 | 3.0 | |
Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure
| Skin reaction | Observation time (following patch removal) | Individual Scores - Rabbit Number and Sex | ||
| A7529 | A7558 | A7559 | ||
| Oedema formation | 1 h | 0 | 3 | 3 |
| 24 h | 3 | 2 | 2 | |
| 48 h | 3 | 2 | 2 | |
| 72 h | 2 | 2 | 2 | |
| Day 7 | 0 | 0 | 0 | |
| Day 14 | 0 | 0 | 0 | |
| Total (24, 48 and 72 hours) | 8 | 6 | 6 | |
| Mean (24, 48 and 72 hours) | 2.7 | 2.0 | 2.0 | |
Note:
All animals: Dryness on Day 7.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the test conditions, the test material ST 03 C 18 is classified as irritant to the skin (Category 2) according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test item (ST 03 C 18) was applied on an undamaged skin area of the flank of 3 male New Zealand White rabbits. On the other flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
A well-defined to moderate erythema was noted on the treated area 1 hour after the patch removal in all animals and was totally reversible between Days 7 and 14.
A moderate oedema was noted on the treated area 1 and 24 hours after the patch removal in all animals and was totally reversible on Day 7.
On the cutaneous structure, dryness of the skin was noted on Day 7 in all animals. The skin recovered a normal aspect on day 14.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.0 / 3.0 / 3.0 for erythema and 2.7 / 2.0 / 2.0 for oedema. These effects are reversible between days 3 and 7.
Therefore, the test material ST 03 C 18 is classified as irritant to the skin (Category 2) according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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.
