Registration Dossier
Registration Dossier
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EC number: 946-134-1 | CAS number: 164651-56-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- July 14, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Green 073:2 - Similar Substance 02
- IUPAC Name:
- Acid Green 073:2 - Similar Substance 02
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z ad libitum
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water ad libitum
Single housing
Weight: mean 2.5 kg
ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µL bulk volume
- Duration of treatment / exposure:
- 24 hours
no rinsing after treatment period - Observation period (in vivo):
- The eyes were examined 24, 48, 72 hours, and 8 days after application of the test substance.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
TOOL USED TO ASSESS SCORE: opthalmoscope
on day 8: fluorescein; investigation under UV light or conalt blue filter after instillation of one drop of fluorescein-sodium solution and rinsing with physiological saline
SCORING SYSTEM: Draize
Evaluation
Evaluation covered pathological findings in the cornea (degree of opacity and area •affected), iris and conjunctivae (reddening, swelling and discharge). Evaluation details were based on the key given below, which was used to determine the irritation score.
Assessment key
From : The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51 (see below)
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:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Lacrimation
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.75
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 110
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Testing for primary eye irritation in the rabbit showed that the substance is not irritating to eyes.
- Executive summary:
Method
The substance was tested for its eye irritation potential according to the Code of Federal Regulations, Title 16, Section 1500.42
100 µL of the test item was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The treated eyes were examined 24, 48 and 72 hours and 8 days after application of the test substance. At 8 days the eyes were also examined for corneal lesions under UV light after instillation of one drop of fluorescein.
Results
No irritant effects were observed, hence the test substance is considered to be not irritating to the eye.
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