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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline, no GLP, but method according to Draize
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method according to Draize, J.H. at al. Methods of the study of irritation and toxicity of substances applied topically to skin and mucous membranes. J. Pharmacol. & Exp. Ther. 82, 377 (1944)
GLP compliance:
no

Test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
All animals kept for 5 days under observation and clinical checks. Animals were housed on macrolon cages and fed standard laboratory diet (pellets) and water ad libitum., except during a 16-hour period prior to treatment.
Initial and final body weights were recorded, mortalities and clinical signs.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml / eye lid (comjuctival sac)
Duration of treatment / exposure:
substance left in the eye for the entire duration of the test.
Scoring was performed at0n3 hour, 24, 72 hours, and after 7 and 14 days
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 rabbits total
Details on study design:
Scaling was based on the grading of Draize.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
at 24 hours
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 5.4
Max. score:
16
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
only one out of three animals showed irritation at 24 hours.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
under the conditions of the test MY 720 was only slightly irritant, but below the value which requires labelling
Executive summary:

under the conditions of the test MY 720 was only slightly irritant, but below the value which requires labelling