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Registration Dossier
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EC number: 947-405-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from NTRL reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- REPORT OF THE INDUSTRIAL TOXICOLOGY SCREENING STUDIES IN RATS, MICE AND RABBITS
- Author:
- NTRL
- Year:
- 1 992
- Bibliographic source:
- NTRL report, 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Principles of method if other than guideline:
- Primary ocular irritation test was performed according to Draize method in albino rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
- EC Number:
- 265-479-2
- EC Name:
- 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
- Cas Number:
- 65122-08-9
- Molecular formula:
- C25H29N2.C2H3O2
- IUPAC Name:
- 1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate - Common Name: Basic Red 12 acetate- Molecular formula:C25H29N2C2H3O2- Molecular weight:416.562 g/mol- Substance type:Organic- Physical state:Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: GAUKLER 6050 OFFENBACH/ maIN- Age at study initiation:no data- Weight at study initiation: rabbit 1- 3.68 kg, rabbit 2- 3.67 kg and rabbit 3- 2.97 kg- Fasting period before study:no data- Housing: stainless steel cages with GRADE GROUND FLAT 40 CM * 50 cm- Diet (e.g. ad libitum): STANDARDIET FOR RABBIT 4mm; FA. SSNIFF-VERSUCHSDIAETEN GmbH, ~ 770 SOEST (Approximately 130 G PER ANIMALS)- Water (e.g. ad libitum): approx 250ml per rabbit, water (monday - friday), tap water (saturday - sunday)- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): 20-26 deg C- Humidity (%):50- 80%- Air changes (per hr):no data- Photoperiod (hrs dark / hrs light): 12h/12 H (6.00 - 18.00 UHR/16.00 - 6.00 UHR)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml undiluted sample
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 1,24,48,72 hours and 8 days after application
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according to Draize method of scoring
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 46
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- moderately to severely irritating to eyes.
Any other information on results incl. tables
Observation Table:
Rabbit | 1 | 2 | 3 |
Rabbit number | 0293 | 0292 | 0271 |
Weight in (kg) | 3.68 | 3.67 | 2.96 |
Gender | NA | NA | NA |
Time (hours) | Animal number | Cornea | Iris | Conjunctiva | Symptom | Mean | |||
TR
| FL
| Rd | SW | SE | |||||
24 | 1 | 1 | 4 | 0** | 0** | 3 | 2 | 50 | 30 |
2 | 1 | 4 | 0** | 0** | 3 | 3 | 50 | 32 | |
3 | 1 | 4 | 0** | 0** | 3 | 3 | 50 | 32 | |
MW |
| 1 | 4 | 0 | 0 | 3 | 3 |
| 31 |
48 | 1 | 2* | 4* | 0** | 0** | 4 | 3 | 52 | 54 |
2 | 2 | 4 | 0** | 0** | 4 | 3 | 50 | 54 | |
3 | 2 | 4 | 0** | 0** | 3 | 3 | 50 | 52 | |
MW |
| 2 | 4 | 0 | 0 | 4 | 3 |
| 53 |
72 | 1 | 2 | 4 | 0** | 0** | 4 | 3 | 50/NA | 54 |
2 | 2 | 4 | 0** | 0** | 4 | 3 | 50/NA | 54 | |
| 3 | 2 | 4 | 0** | 0** | 3 | 3 | 50/NA | 52 |
MW | 2 | 4 | 0 | 0 | 4 | 3 |
| 53 | |
8 DAYS | 1 | 4 | 2 | 0** | 2 | 4 | 3 | 50/NA/E | 58 |
| 2 | 4* | 2* | 0** | 2* | 4 | 3 | 50/NA/E | 58 |
| 3 | 4* | 2* | 0** | 2* | 4 | 3 | 50/NA/E | 58 |
| MW | 4 | 2 | 0 | 2 | 4 | 3 |
| 58 |
HIGH REMOVAL PROVISIONS (BASIC SEE SYMPTOM):
*-HAVE BEEN TAKEN TO AN OFFICIAL DATE 1 - 2 ANIMAL ACTIVITIES THE GOOD WORK IS NOT POSSIBLE. SO ROUNDED VALUES SHOULD BE OBSERVED
**- HAVE BEEN TAKEN TO AN OFFICIAL DATE 1 - 2 ANIMAL ACTIVITIES THE GOOD WORK IS NOT POSSIBLE. So ROUNDED VALUES SHOULD BE OBSERVED
Evaluation of symptoms:
50- NO VALUE OF THE TRAVELING POINTS
52 -REPORTS NOTES OBSERVED TO OVERHEAD LEVELS
E -Terminated
NA - NA
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Primary eye irritation study for test chemical was performed in albino Vienna White rabbits according to Draize method. The Mean score after 8 days was 46.Based on the score,test chemical was considered to be moderately to severely irritating to eyes.
- Executive summary:
Primary eye irritation study for test chemical was performed in albino Vienna White rabbits according to Draize method.
0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from1,24,48,72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize.The Mean score after 8 days was 46.
Based on the score, test chemical was considered to be moderately to severely irritating to eyes.
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