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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 272-447-1 | CAS number: 68845-00-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Cas Number:
- 125673-86-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Reference substance name:
- rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane
- Reference substance name:
- 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- EC Number:
- 250-657-4
- EC Name:
- 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- Cas Number:
- 31499-72-6
- Molecular formula:
- C13H22O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- Test Material: Boisiris
Batch No.: 149135
Aspect: colourless liquid
Storage conditions: stored in the dark under ambient conditions
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- One male and two female (nulliparous and non-pregnant) young adult New Zealand White rabbits were used. They were supplied by Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire and arriveds at Elphinstone Research Centre on 24 May 1988.
The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
The rabbits were fed Rabbit Diet, supplied by Special Diet Services and allowed food and tap water ad libitum. The diet and water are analysed on a regular basis and meet the criteria laid down by IRI.
Mean environmental maximum and minimum temperatures were 19 °C and 17 °C and mean relative humidity was 58%. At 12 h light/dark cycle was in operation (light hours 0700 - 1900 h)
The rabbits were allowed an acclimatisation period of 7 days before test commencement.
The rabbits were uniquely identified within the study by means of an indelible number on the inner surface of the ear.
Test system
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml was applied to intact skin on each rabbit under a 2.5 cm x 2.5 cm patch of gauze.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were assessed 1, 24, 48 and 72 hours after each patch removal.
- Number of animals:
- 3 animals (one males and two females)
- Details on study design:
- The patch was covered with Mircopore tape and the trunk was loosley bound with Elastoplast Elastic Bandage which remained in position for 4 hours. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated site at 1h, 24 h and 48 h after patch removal. No oedema was noted and the treated site had returned to normal at 72 h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Boisiris is pratically non-irritant to rabbit skin.
- Executive summary:
Boisiris is not a skin irritant.
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.
