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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 301-037-8 | CAS number: 93980-59-7
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Sep 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sorbitan, tridocosanoate
- EC Number:
- 301-037-8
- EC Name:
- Sorbitan, tridocosanoate
- Cas Number:
- 93980-59-7
- Molecular formula:
- C72H138O8
- IUPAC Name:
- Sorbitan tridocosanoate
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Hokkaido Livestock Corporation, Douo Plant, Hayakita Factory
- Number of eyeballs: 30, 12 used in the study
- Characteristics of donor animals: 12 months to less than 60 months old, healthy
- Storage, temperature and transport conditions of ocular tissue: The collected eyeballs were immersed in Hanks' balanced salt solution, and stored and transported at less than 20°C until use in the test (temperature range during transportation: 12 - 14°C).
- Time interval prior to initiating testing: same day
- Indication of any existing defects or lesions in ocular tissue samples: no
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: 10% (w/v)
VEHICLE
- Amount(s) applied: 8 mL
- Concentration: undiluted
- Lot/batch no.: K7D7 - Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- triplicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: A careful macroscopic examination was performed on all eyes to detect the presence of any defects (corneal opacity, scratches, neovascularization etc). Any eyes with defects were discarded. The corneas were dissected with a 2 to 3 mm rim of the sclera remaining, and were immersed in Hanks' balanced salt solution (HBSS). The corneae were directly used in the BCOP test on the same day.
QUALITY CHECK OF THE ISOLATED CORNEAS : Eyes were free of defects.
NUMBER OF REPLICATES : 3
SOLVENT CONTROL USED: yes, distilled water
POSITIVE CONTROL USED : yes, Dimethylformamide
APPLICATION DOSE AND EXPOSURE TIME : 750 μL test item (10%), 10 min
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times with phenol red-containing MEM and 1 time with phenol red-free MEM
- POST-EXPOSURE INCUBATION: yes, 2 h
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured using the opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria as indicated in the TG (OECD 437) was used.
STUDY ACCEPTANCE CRITERIA: The following study acceptance criteria described in OECD TG 437 were adopted:
A test is considered acceptable if the IVIS of the positive control is within 2 standard deviations of the latest historical control mean. A test is considered acceptable if the opacity and permeability values of the negative control are less than the upper limit of opacity and permeability values of the historical control data obtained from the bovine corneas treated with the negative control.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Negative control (Mean corrected final opacity)
- Value:
- 0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- (Permeability)
- Run / experiment:
- Negative control (Mean corrected OD490 change)
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Negative control
- Value:
- 0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test substance (Mean corrected final opacity)
- Value:
- -0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- (Permeability)
- Run / experiment:
- Test substance (Mean corrected OD490 change)
- Value:
- -0.001
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test substance
- Value:
- -0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Positive control (Mean corrected final opacity)
- Value:
- 95.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- (Permeability)
- Run / experiment:
- Positive control (Mean corrected OD490 change)
- Value:
- 0.77
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Positive control
- Value:
- 107.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
not demonstrated in the study report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline:
Opacity
Negative control: -2.0 - 2.4
Positive control: 38.0 - 111.0
Permeability
Negative control: -0.003 - 0.027
Positive control: 0.171 - 1.708
IVIS:
Negative control: -2.0 - 2.4
Positive control: 42.3 - 128.0 (mean ± 2SD: 67.4 ~ 128.2)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
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.
