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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-380-4 | CAS number: -
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-09-29 to 2008-10-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- , 2002-04-24
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2007-10-15
Test material
- Reference substance name:
- 700-380-4
- EC Number:
- 700-380-4
- Molecular formula:
- A: C25H50O2 B: C27H54O2
- IUPAC Name:
- 700-380-4
- Details on test material:
- - Name of test material (as cited in study report): Sym08/181598
- Synonym: SymMollient S
- Molecular formula: A: C25H50O2; B: C27H54O2
- Molecular weight: A: 382.68 g/mol; B: 410.73 g/mol
- Physical state: Colourless liquid to solid
- Storage condition of test material: Ambient temperature (10 - 30 °C), dark, dry, in original container
No further information on the test material was stated.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: weight range of 2.0 to 3.5 kg (Animal no. 1: 2.63 kg; Animal No. 2: 2.77 kg and Animal No. 3: 2.43 kg)
- Housing: The animals were individually housed in suspended cages.
- Diet (ad libitum): 2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (ad libitum): Mains drinking water
- Acclimation period: At least five days
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Relative humidity: 30 to 70 %
- Air exchanges: At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test material remained in the liquid phase during the study.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): For the purpose of the study the test material was used as supplied. For the duration of the study, the test material remained in the liquid phase.
A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes.
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- see amount/concentration applied
- Observation period (in vivo):
- Approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 male rabbits (Initial, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.)
- Details on study design:
- SCORING SYSTEM:
Draize scoring system was used.
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
OTHER OBSERVATIONS:
Any other ocular effects were also noted. Body weight was recorded on Day 0 and Day 3 and body weight changes were recorded. Immediately after administration of the test material, an assessment of the inital pain reaction was made according to a six point scale shown in table 2 (see "Any other information om materials and methods incl. tables" below).
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatemtn with minimal conjunctival irritation noted at the 24-hour observation.
Minimal discharge was only seen at the 1-hour observation.
All treated eyes appeared normal at the 48-hour observation. - Other effects:
- All animals showed expected gain in body weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as an eye irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as an eye 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.
