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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Test article: CGA 224443
- Batch No.: P. 810012
- Purity: 92,6%
- Physical properties: liquid
- Storage conditions: room temperatur
- Date of reanalysis: December 31, 1991
- Safety precautions: gloves and face masks
- Test material received: March 6, 1990

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- 3 female Animals
- Age at study initiation: 9 - 13 weeks old
- Weight at study initiation: 2170 to 2500 g
- Housing: individually in metal cages
- Identification: by ear tattoo
- Diet (e.g. ad libitum): standard rabbit pellet - Nafag No. 814 and fresh water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as a control
Duration of treatment / exposure:
0,1 ml of CGA 224443 was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.
Observation period (in vivo):
the ocular reactions were evaluated 1, 24, 48, 72 hours after the installation of CGA 224443
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
a slit-lamp was used to facilitate the evaluation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hrs
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72
Score:
1.33
Max. score:
2
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information