Registration Dossier
Registration Dossier
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EC number: 224-115-2 | CAS number: 4203-77-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June 05, 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The substance has been tested according to accpeted guideline but the content of the active ingredient in the test substance is very low.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Version / remarks:
- 1959
- GLP compliance:
- no
Test material
- Reference substance name:
- Vat Red 013
- IUPAC Name:
- Vat Red 013
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: animals housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit food - NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 8 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- 3 per sex per dose
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: after 30 sec of exposure
SCORING SYSTEM: according to the guideline
TOOL USED TO ASSESS SCORE: slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not eye irritant
- Executive summary:
Method
The procedure used was the test for eye irritants described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
The test was performed on 3 male and 3 female rabbits. 0.1 g was inserted into the conjunctival sac of the left eye of 6 rabbits and
the lids were gently held open for one second. The right eye remained untreated and served as a control.
Results
No signs of irritation were observed in none of the animals therfore the substance resulted not irritant to the eye, under this test conditions.
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