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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
trimethylsulfanium bromide
EC Number:
678-448-7
Cas Number:
3084-53-5
Molecular formula:
C3H9BrS
IUPAC Name:
trimethylsulfanium bromide
Specific details on test material used for the study:
Lot No.: 21MR1-2
Purity: 99%

Test animals / tissue source

Species:
other: Bovine cornea
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: Spear Products Inc., 520 Springfield street, coopersburg, PA 18036.
- Number of animals: 9 corneas
- Selection and preparation of corneas: Eyes were carefully examined for defects (opacity, scratches, pigmentation, etc) shortly after arrival to the facility. Any eyes with defects were omitted from the study and discarded. The tissue surrounding the eye ball was carefully pulled away, and the cornea was excised, leaving a rim of sclera approximately 2 to 3 mm wide. The isolated corneas were maintained in HBSS until all were dissected.

Test system

Vehicle:
water
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 uL
- Concentration (if solution): 20% w/v
Duration of treatment / exposure:
4 hours
Duration of post- treatment incubation (in vitro):
90 mins
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: washed at least 3 times with MEM containing phenol red until no color change occurred.

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490)

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: the decision criteria as indicated in the TG was used.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
-1
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
TMSBr meets the requirements of EPA category III and UN GHS no category for the BCOP test.
Proper conduct of the BCOP was confirmed via a positive response with imidazole and a negative response with 0.9% sterile NaCl.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
TMSBr is not irritating to eyes in the BCOP test.
Executive summary:

The Bovine corneal opacity & permeability assay was performed using isolated bovine cornea, according to OECD Guideline 437 under GLP.


TMSBr is not irritating to eyes in the BCOP test.