Registration Dossier
Registration Dossier
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EC number: 274-700-1 | CAS number: 70616-89-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1963
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
Test material
- Reference substance name:
- Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate
- EC Number:
- 274-700-1
- EC Name:
- Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate
- Cas Number:
- 70616-89-6
- Molecular formula:
- C24H18ClN7O10S3.3Na
- IUPAC Name:
- trisodium 2-({6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonato-2-naphthyl}azo)naphthalene-1,5-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identity FAT 40170/E TEBatch Ref No. 6293 (India)Appearance red brown powder at 20°CSmell neutralpH-Value pH-value of a solution of 2% (w/w) = 6.2Expiration date October 14th, 2019Storage to be stored at room-temperature
Constituent 1
- Specific details on test material used for the study:
- None
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf- Age at study initiation: 12 - 14 weeks- Weight at study initiation: 2130-2560 g- Housing: Animals were housed individually in metal cages.- Diet (e.g. ad libitum): rabbit food ad libitum- Water (e.g. ad libitum): water ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 20±3° C- Humidity (%): 30-70 %- Air changes (per hr): approximately 15 air changes/h.- Photoperiod (hrs dark / hrs light): 12 hours light/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- not specified
- Amount / concentration applied:
- 0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal
- Duration of treatment / exposure:
- The lids were then held together for about one second in order to prevent loss of the test material.
- Duration of post- treatment incubation (in vitro):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- None
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- None
- Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40170 is considered to be a non-irritant to the eyes.
- Executive summary:
In a study performed to determine the eye irritation potential of FAT 40170, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1, 24, 48 and 72 hours. The body weight in 1 animal was decreased during the test period. No other reactions to treatment were recorded during the whole observation period. Based on these findings, FAT 40170 is considered to be a non-irritant to the eyes.
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