Registration Dossier
Registration Dossier
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Reaction mass of sodium(E)-6,7'-carbonylbis(azanediyl)bis(4-hydroxy-3-((E)-phenyldiazenyl) naphthalene-2-sulfonate) and disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate and disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]
EC number: 939-268-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 12 to 26 march 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
Test material
- Reference substance name:
- Direct red 23
- IUPAC Name:
- Direct red 23
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: single application of 0.1 ml (76.6 mg) - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 1, 24, 48 amd 72 hours and 7 days after administration
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: All rabbits (65967, 66032 and 66033 males)
- Time point:
- 24/48/72 h
- Score:
- ca. 10
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- other: all animals
- Time point:
- 7 d
- Score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material produced moderate conjunctival irritation.
Dark red-coloured staining of the lower conjunctival and nictitating membranes and red-coloured staining of the fur around the treated eye were also noted. One treated eye appeared normal at the 72-hour observation and the two remaining treated eyes appeared normal atthe 7-day observation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE)
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC. - Executive summary:
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09), The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Initation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).
Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE). The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC
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