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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-308-1 | CAS number: 1335203-19-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dec-1-ene, dimers, hydrogenated
- EC Number:
- 500-228-5
- EC Name:
- Dec-1-ene, dimers, hydrogenated
- Cas Number:
- 68649-11-6
- Molecular formula:
- C20H42
- IUPAC Name:
- Hydrogenated dimerization products of 1-decene
- Reference substance name:
- 1-decene dimer, hydrogenated
- IUPAC Name:
- 1-decene dimer, hydrogenated
- Details on test material:
- - Name of test material (as cited in study report): MCP 922
- Physical state: liquid
- Expiration date of the lot/batch: 06/25/1991
- Stability under test conditions: 2 years under room temperature
- Storage condition of test material: ventilation
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products Inc (Denver, PA)
- Age at study initiation: young adult
- Housing: individually housed in suspended cages with wire mesh bottoms
- Diet (e.g. ad libitum): 125g Purina Rabbit Chow No.5326 provided daily
- Water (e.g. ad libitum): ad libitum via an automatic watering system
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-72
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Duration of treatment / exposure:
- Test substance instilled into left conjunctival sac
- Observation period (in vivo):
- Both eyes grossly examined and the test eye scored according to the Draize method at 1, 24, 48, and 72 hours after administration. If ulcerations persist at 72 hours the eyes will be observed at 7, 10, 14, and 21 days or until clear. Other observations such as vascular keratitis will also be recorded.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize Method
TOOL USED TO ASSESS SCORE: Sodium fluorescein 2%
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 28, 72h
- Score:
- 0
- Remarks on result:
- other: 6 animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Remarks on result:
- other: 6 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 2
- Remarks on result:
- other: 6 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: 6 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24hrs
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 out of 6 animals had a score of 2; the rest had scores of 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The test material produced 1/6 positive reactions to conjunctival redness according to the FHSA guidelines.
- Other effects:
- Clinical observations: soft stool, decreased food consumption, and decreased fecal output was noted in one or more animals. The mean corenal opacity, iritis conjuntivae redness and chemosis mean scores following grading at 24, 48, and 72 h for animal #1 were 0,0,1,1 animal #2 were 0,0,0.6,1; animal #3 were 0,0,1,1; animal #4; 0,0,1.2,1; animal #5 were 0,0,1,1; and animal #6 were 0,0,1,1. Conclusions on revesibility are limited based on the lenght of the study (concluded after 72h)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean corneal opacity, iritis, conjunctivae redness, and chemosis scores for the test material were 0, 0, 1 and 1, respectively. These findings do not warrant classification of the test material as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The test material was administered to the left eye of three male and three female rabbits to assess for ocular irritation. Ocular examinations occurred at 1h, 24h, 48h, 72h post-dosing and the animals were observed for remaining ocular lesions day 7, 14, 21, or until clear. Ocular damage was assessed and scored according to the Draize eye test. The mean corneal opacity, iritis, conjunctivae redness, and chemosis scores for the test material at each time point were all less than or equal to one for 5 out of 6 animal. One animal had a scoreof 2 for conjunctivae redness at 24 hours. The mean corenal opacity, iritis conjuntivae redness and chemosis mean scores following grading at 24, 48, and 72 h for animal #1 were 0,0,1,1 animal #2 were 0,0,0.6,1; animal #3 were 0,0,1,1; animal #4; 0,0,1.2,1; animal #5 were 0,0,1,1; and animal #6 were 0,0,1,1. Conclusions on revesibility are limited based on the length of the study (concluded after 72h). These findings do not warrant classification of the test material as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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.
