Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable publication, basic data given

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1990

Materials and methods

Principles of method if other than guideline:
Three healthy female rabbits (2.0 - 2.2 kg) were used. Test substance (100 mg of solid) was placed into the conjunctival sac of the left eye. The right eye served as control. Evaluation according to DRAIZE score 1, 4, 24, 48, 72, 96 hours and 7, 14 and 21 days after treatment. Eye irritation score and recovery from corneal and conjuctive damage was assessed.

Test material

Constituent 1
Chemical structure
Reference substance name:
Indometacin
EC Number:
200-186-5
EC Name:
Indometacin
Cas Number:
53-86-1
Molecular formula:
C19H16ClNO4
IUPAC Name:
2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese (white rabbits, Breeder: Takeo, Shizuoka, Japan)

Test system

Vehicle:
unchanged (no vehicle)
Observation period (in vivo):
for 21 days after treatment
Number of animals or in vitro replicates:
3

Results and discussion

Any other information on results incl. tables

Indomethacin was non-or mild irritant (minimal irritation recovering within 24 hours)

Applicant's summary and conclusion