Registration Dossier
Registration Dossier
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EC number: 233-651-6 | CAS number: 10291-28-8
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: Guideline study (OECD TG 405).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,5-bis(p-toluidino)terephthalic acid
- EC Number:
- 233-651-6
- EC Name:
- 2,5-bis(p-toluidino)terephthalic acid
- Cas Number:
- 10291-28-8
- Molecular formula:
- C22H20N2O4
- IUPAC Name:
- 2,5-bis[(4-methylphenyl)amino]benzene-1,4-dicarboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): Toluidinosäure gemahlen
- Substance type: brown particulates.
- Storage condition of test material: in the darkness at 22 °C in a fume cupboard.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed.
- Weight at study initiation: 2.3-2.5 kg.
- Housing: individually.
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum.
- Water: deionised, chlorinated water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg pasted with 0.05 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen). - Duration of treatment / exposure:
- 24 h.
- Observation period (in vivo):
- 72 h.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with ca. 37 °C warm physiol. saline.
- Time after start of exposure: 24 h and 72 h.
SCORING SYSTEM: according to OECD TG 405.
TOOL USED TO ASSESS SCORE: fluorescein, UV light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h.
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- - no signs of irritation at any time
- Irritation parameter:
- iris score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h.
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- - no signs of irritation at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h.
- Score:
- 0
- Reversibility:
- other: initial slight redness was fully reversible within 24h
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h.
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- - no signs of irritation at any time
- Irritant / corrosive response data:
- One hour after application conjunctival redness score 1 was observed in every animal, fully reversible within 24 h. No other eye responses were noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Test material toluidino acid is not irritating under these test conditions.
- Executive summary:
Test material toluidino acid was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No severe or persisting eye responses were observed. The substance is found to be not irritating under these test conditions.
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