Registration Dossier
Registration Dossier
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EC number: 407-230-4 | CAS number: 126637-70-5 BLUE GS 1259 R5
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-11-21 to 1991-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)
- EC Number:
- 407-230-4
- EC Name:
- Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)
- Cas Number:
- 126637-70-5
- Molecular formula:
- Hill formula: C32 H16 Cu2 Li2 N6 Na2 O16 S4 CAS formula: C32 H16 Cu2 N6 O16 S4. 2Li 2Na
- IUPAC Name:
- dicopper(2+) dilithium(1+) disodium 4,4'-bis[2-(8-amino-1-oxido-3,6-disulfonatonaphthalen-2-yl)diazen-1-yl]-[1,1'-biphenyl]-3,3'-bis(olate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2789 - 2953 grams
- Housing: Individually in cages with perforated floors equipped with an automatic drinking-system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 gram per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: At least five days before start of treatment under test conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 1990-11-21 To: 1990-12-03
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 48 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Immediately after fluorescein examination on day 2, both eyes of all three animals were rlnsed with approx 100 ml tepid tap-water
- Time after start of exposure: 48 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed irritating effect: Changes fully reversible within 7 days.
There was no evidence of ocular corrosion. - Other effects:
- Blue discolouration of iris, eyelids (treated eye) and fur.
No toxic symptoms were observed i n the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information mildly irritating (M2) Criteria used for interpretation of results: EU
- Conclusions:
- The test substance should be considered mildly irritating (M2) to the rabbit eye. According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC), the substance needs not be labelled as an eye irritant. The same conclusion applies to the new CLP regulation EC 1272/2008.
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