Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 April 1999 - 4 June 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline and GLP. The report is however very concise and does not contain full details on methods and results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The report is however very concise and does not contain full details on methods and results.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name : Rhodiastab X7
Lot or Batch Number : 9801511
Date received : 9th April 1999
Description : White powder
Container : Clear glass bottle
Storage at RTC : Ambient conditions
RTC reference number: 3807
Purity: 95.0%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1 hour
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
No data

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
other: the study was terminated after 1 hour
Irritation parameter:
cornea opacity score
Remarks:
involved area
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
other: the study was terminated after 1 hour
Irritant / corrosive response data:
The study was terminated after a hour as severe irritation was apparent. No further details.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibilty of these effect and the scores at all the highest level the substance is classified corrosive to the eyes.
Executive summary:

A eye irritation/corrosion study was performed according to OECD guidelines and GLP. In a single animal 0.1 g of test substance was instilled in the eye. The study was terminated after a hour as severe irritation was apparent. No further details. Since it is not possible to judge the reversibility of these effect and the scores are at the highest level the substance is classified corrosive to the eyes.