Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ra 3643 bxa
- Substance type: white powder
- Physical state: solid
- Expiration date of the lot/batch: January 4, 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
3 males
- Source: Conelli snc Arona (Novara) Italy
- Age at study initiation: 2-3 months
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): GLP 2 RB 15 certificate pelletted diet; the content were crude protein (13.2%), crude fat (2.5%, crude fiber (22%),l crude ash (9.5%). The diet was supplemented with vitamins and trace elements. The diet was available ad libitum.
- Water (e.g. ad libitum): from the municipal water main system. Ad libitum.
- Acclimation period: about 2.5 months

ENVIRONMENTAL CONDITIONS
individual caging in T05C air conditioned room
- Temperature (°C): 20°C +/- 2
- Humidity (%): 50+/- 15
- Air changes (per hr): about 15/hour
- Photoperiod (hrs dark / hrs light): artificial lighting with a circadian cycle of 12 hours of light (7am-7pm)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 g/animal
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
at 1,24,48 and 72 hours after the application. After the 24-hour reading the cornea were examined after instillation of one drop of 1% sodium fluorescein and subsequent washing out with sterile salin
Number of animals or in vitro replicates:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

No animals died and no general clinical signs were seen in any animal.

At the application site, slight reversible ocular changes were evident in two out of the three treated rabbits at 1 hour after treatment and lasting up to 24 hours in one of them. no signs were evident 48 hours after the application in any animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was considered non irritant for the eye.