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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Boldenone
EC Number:
212-686-0
EC Name:
Boldenone
Cas Number:
846-48-0
Molecular formula:
C19H26O2
IUPAC Name:
17-hydroxyandrosta-1,4-dien-3-one
Details on test material:
- Name of test material (as cited in study report): boldenone (ZK5320)
- Analytical purity: 99%
- Lot/batch No.: 8145-3/08
- Expiration date of the lot/batch: 11 Jul 2011

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Duration of treatment / exposure:
test substance remained in eye and was not flushed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2/sex

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 71 hours
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 7
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0

Any other information on results incl. tables

Local findings were slight hyperemia at the iris, slight to moderate reddening and slight to severe swelling of the conjunctivae in all animals on administration day. On day 2 and 3 slight reddening or slight swelling of conjunctivae was noted in 3/4 animals, one animal showed still hyperemia at the iris and moderate reddening and severe swelling. In this animal slight reddening was observed up to day 7, slight swelling was seen up to day 5 and hyperemia after excitement occurred on day 7. All animals were without findings on day 8 of the test.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no irreversible effect of boldenone found. Classification is not required
Executive summary:

The single administration of boldenone (ZK 5320) to the right eye of male and female rabbits results in slight to severe transient irritation on the rabbit conjunctiva and slight to moderate hyperemia on the iris on day 1 and day 2 which decreased from day 3 onwards and were fully reversible on day 8 after administration.