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EC number: 274-395-5 | CAS number: 70209-97-1
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Terrestrial toxicity
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- 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
- Study period:
- 30 October 1995 to 06 November 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate
- EC Number:
- 274-395-5
- EC Name:
- Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate
- Cas Number:
- 70209-97-1
- Molecular formula:
- C25H22ClN5O7S2.Na
- IUPAC Name:
- sodium 2-({2-amino-8-hydroxy-6-[(2-methylphenyl)sulfamoyl]-1-naphthyl}diazenyl)-5-[(chloroacetyl)amino]benzenesulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
1.56
- Expiration date of the lot/batch:
June 2000
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In refrigerator (ca. 4 °C) protected from sunlight
- Stability under storage conditions:
stable at storage conditions
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
- Age at study initiation: 13 weeks
- Weight at study initiation: male : 2.2 kg; females: 2.2 - 2.3 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: Pelleted standard Kliba 341, Batch no. 91/95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark
IN-LIFE DATES: From: October 25, 1995 To: December 12, 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1 male and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- No corrosion of the cornea was observed at any of the reading times.
- Other effects:
- - Swelling of the conjunctivae was reversible after seven days.
- Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.
- Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.
Any other information on results incl. tables
VIABILITY / MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
IRRITATION
FAT 20'075/B showed a primary irritation score of: 1.11, when applied to the conjunctival sac of the rabbit eye. Slight-to-moderate swelling of the conjunctivae was noted in all animals but was reversible after seven days. Slight-to-moderate watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.
COLORATION
Light red or red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.
CORROSION
No corrosion of the cornea was observed at any of the reading times.
BODY WEIGHTS
The body weight of the animals was within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20075/B is classified as "not irritating" to the rabbit eye.
- Executive summary:
Primary eye irritation study in rabbits with FAT 20075/B was conducted according to OECD 405 guideline and in accordance with GLP in 1995. The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult (1 male and 2 female) New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of the animals was within the normal range of variability. It was found to be 1.11, when applied to the conjunctival sac of the rabbit eye. Swelling of the conjunctivae was reversible after seven days. Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days. Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. No corrosion was observed at any of the measuring intervals. Based on the study results FAT 20075/B is classified as "not irritating" to the rabbit eye.
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