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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
and Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 - 4 months
- Weight at study initiation: 2.8 ± 0.3 kg
- Housing: individually in polystyrene cages (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): ad libitum, 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water (filtered)
- Acclimation period: 5 days (at least)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

VEHICLE
No vehicle
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test item.
Observation period (in vivo):
1h, 2h, 48h, 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed after administration of the test item.
SCORING SYSTEM: Xi symbol

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24 h
Score:
0.7 - 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: chemosis - redness
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24 h, 48h, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Slightly irritant ti rabbit eye.
Other effects:
Notes: Max score: 2 (one animal, conjunctivae. 24 h).

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified.