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A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
EC number: 403-410-1 | CAS number: 114565-65-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the OECD TG 405 and followed GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
- EC Number:
- 403-410-1
- EC Name:
- A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
- Cas Number:
- 114565-65-0
- Molecular formula:
- C18 H16 N8 O3 S2 . x C7 H18 N2 . x C4 H11 N O2 . x C3 H9 N O
- IUPAC Name:
- (3-aminopropyl)diethylamine; 2-(methylamino)ethan-1-ol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 6-methyl-2-{4-[2-(triaminopyrimidin-5-yl)diazen-1-yl]phenyl}-1,3-benzothiazole-7-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): FAT 11'184/B
- Physical state: powder
- Analytical purity: No data mentioned in the report. However, in an Ames test report (CCR 124312, see IUCLID chapter 7.6.1) using the same batch of test substance the analytical purity was given as 89.6%.
- Lot/batch No.: Op. 1 BD 823/8
- Expiration date of the lot/batch: January, 1993
- Stability under test conditions: test substance in dilution is stable for at least 2 hours
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Designation: New Zealand White, KFM (SPF-Quality)
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 3 - 3.1 kg
- Housing: individually in stainless steel cages with automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341, Batch 32/87 rabbit maintenance diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served for control
- Amount / concentration applied:
- The test article was applied undiluted (0.1 g per animal) in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article.
- Duration of treatment / exposure:
- The treated eyes were not rinsed; the first examination was done one-hour after instillation of the test article in the conjunctival sac. Further examinations were conducted after 24, 48 and 72 hours, 7, 14 and 21 days following treatment.
- Observation period (in vivo):
- The observation was terminated 21 days after administration of the test article. All rabbits were then sacrificed and discarded.
- Number of animals or in vitro replicates:
- Three animals (one male and 2 females) were used.
- Details on study design:
- The irritation was assessed according to the OECD guideline and the findings were scored according to the numerical Draize scoring system.
Eye examinations were made with a slit-lamp 30 SL (C. Zeiss AG, Zuerich / Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2 and 3, respectively
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects seen in the iris
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- In animal 1, corneal opacity graded 1 was seen at reading time point (RTP) 72 h, 7 d and 14 d; conjunctival redness graded 2 was seen at RTP 1, 24, 48 and 72h, and had turned slight (grade 1) on 7d; thereafter no redness was evident; chemosis was graded 2 at RTP 1 h and 1 thereafter, at RTP 24, 48 and 72 h. The iris was inconspicuous. Discharge reaching from severe to slight was observed until RTP 14 d whereas an orange discoloration of the eye lasted until RTP 7 days. Complete reversibility of all findings was attained after 21 days.
In animal 2, corneal opacity graded 1 was seen at reading time point (RTP) 24 h, 48 h, 72 h, 7 d and 14 d; conjunctival redness graded 2 was seen at RTP 1, 24, 48 h, and had turned slight (grade 1) at 72 h; thereafter no redness was evident; chemosis was graded 2 at RTP 1 h and 1 thereafter, at RTP 24 and 48 h. The iris was inconspicuous. Discharge reaching from severe to slight was observed until RTP 48 h whereas an orange discoloration of the eye lasted until RTP 7 days. Complete reversibility of all findings was attained after 21 days.
In animal 3, corneal opacity graded 1 was seen at reading time point (RTP) 72 h and 7 d; conjunctival redness graded 2 was sen at RTP 1, 24, 48 h, and had turned slight (grade 1) at 72 h; thereafter no redness was evident; chemosis was graded 2 at RTP 1 h and 1 thereafter, at RTP 24 and 48 h. The iris was inconspicuous. Discharge reaching from severe to slight was observed until RTP 48 h whereas an orange discoloration of the eye lasted until RTP 7 days. Complete reversibility of all findings was attained after 14 days. - Other effects:
- Discharge, initially severe becoming slight in the course of time, was seen in all 3 animals (animal 1 until day 14, animal 2 until 48 h, animal 3 until 48 h).
In the area of application a orange staining of the cornea and conjunctivae by pigment or coloring of the test article was observed, which lasted for 7 days in each of the 3 animals.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.The body weight gain of all rabbits was similar.
Any other information on results incl. tables
Eye Finding (Scoring according to Draize):
Animal 1 |
||||||
Reading time point |
Eye Findings (Scoring according to Draize) |
|||||
Cornea opacity |
Iris |
Conj. Redness |
Chemosis
|
Discharge |
Discoloration |
|
1 h |
0 |
0 |
2 |
2
|
severe |
yes |
24 h |
0 |
0 |
2 |
1
|
severe |
yes |
48 h |
0 |
0 |
2 |
1 |
severe |
yes
|
72 h |
1 |
0 |
2 |
1
|
slight |
yes |
7 d |
1 |
0 |
1 |
0
|
slight |
yes |
14 d |
1 |
0 |
0 |
0
|
slight |
none |
21 d |
0 |
0 |
0 |
0
|
none |
none |
Animal 2 |
||||||
Reading time point |
Eye Finding (Scoring according to Draize) |
|||||
Cornea opacity |
Iris |
Conj. Redness |
Chemosis
|
Discharge |
Discoloration |
|
1 h |
0 |
0 |
2 |
2
|
severe |
yes |
24 h |
1 |
0 |
2 |
1
|
moderate |
yes |
48 h |
1 |
0 |
2 |
1 |
slight |
yes
|
72 h |
1 |
0 |
1 |
0
|
none |
yes |
7 d |
1 |
0 |
0 |
0
|
none |
yes |
14 d |
1 |
0 |
0 |
0
|
none |
none |
21 d |
0 |
0 |
0 |
0
|
none |
none |
Animal 3 |
||||||
Reading time point |
Eye Finding (Scoring according to Draize) |
|||||
Cornea opacity |
Iris |
Conj. Redness |
Chemosis
|
Discharge |
Discoloration |
|
1 h |
0 |
0 |
2 |
2
|
severe |
none |
24 h |
0 |
0 |
2 |
1
|
moderate |
yes |
48 h |
0 |
0 |
2 |
1 |
slight |
yes
|
72 h |
1 |
0 |
1 |
0
|
none |
yes |
7 d |
1 |
0 |
0 |
0
|
none |
yes |
14 d |
0 |
0 |
0 |
0
|
none |
none |
21 d |
0 |
0 |
0 |
0
|
none |
none |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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