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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
2 (reliable with restrictions)

Data source

Reference Type:
other: Authoritative data base
HSDB Number : 564
Bibliographic source:
HSDB (Hazardous Substances Data Bank); Kirk-Othmer Encyclopedia of Chemical Technology. 4th ed. Volumes 1: New York, NY. John Wiley and Sons, 1991-Present., (95) 727

Materials and methods

Test guideline
according to guideline
Principles of method if other than guideline:
3 white Vienna rabbits/ ... were dosed by single application of 0.1 mL of undiluted test substance to the conjunctival sac of the right eye, the substance was not washed out.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Cas Number:

Test animals / tissue source

Vienna White

Test system

unchanged (no vehicle)

Results and discussion

In vivo

Irritation parameter:
overall irritation score
Time point:
other: 15 h
not fully reversible within: 15 d
Remarks on result:
other: The untreated eye served as the negative control

Any other information on results incl. tables

After 1 hour, all three animals showed well defined chemosis andconjunctival redness plus clearly to distinctly increased eye discharge; additionally, 1/3showed contracted pupil. After 1 day, all animals showed slight corneal opacity with atleast one-quarter of the cornea involved, well defined to severe conjunctival redness,slight to no chemosis and slightly increased discharge; this pattern remained foranother day (day 2); on both days 1 and 2, 2/3 animals showed contracted pupils andone of the loss of corneal tissue. On day 3 slight corneal opacity was distributed overat least half of the cornea, the iris showed circumcorneal injection and there was stillwell-defined to severe redness, but chemosis and discharge were only remarkable in1/3 animals.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes)
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Since all three animals showed contracted pupils, loss of corneal tissue and 1/2had small retractions in the eyelid for the read across analog substance but the same cannot be considered for the target substance. On day 8, with the exception of slight cornealopacity in one male, all animals were free of quantified symptoms, one male showedsmall eyelid retractions, marginal vascularization of the cornea, loss of hair at marginsof eyelids and loss of corneal tissue. On day 15, there were no quantified reactions in any animal, but one male still showed small retractions of the eyelid and loss of hair atthe margins of the eyelid.

Based on this data for eye irritation it can be concluded that the target substance will qualify for mild eye irritation in the catergory 2 as per the CLP regulation.