Registration Dossier
Registration Dossier
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EC number: 269-323-4 | CAS number: 68223-93-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Reg 92/69/EEC B.5 (1992-07-31)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diammonium 2,2'-dithiodiacetate
- EC Number:
- 269-323-4
- EC Name:
- Diammonium 2,2'-dithiodiacetate
- Cas Number:
- 68223-93-8
- Molecular formula:
- C4H6O4S2.2H3N
- IUPAC Name:
- diammonium 2-[(carboxymethyl)disulfanyl]acetate
- Test material form:
- other: liquid
- Details on test material:
- Lot# 4683
assay: 48,1%w/w iodometric
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.7+/-0.2 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay sur Orge, France) ad libitum
- Water (e.g. ad libitum): filtered drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Test material: Diammonium 2,2'-dithiodiacetate 48% in water
one single dose of 0.1 ml test material (undiluted) was administered.
All animals sceamed just after the treatment. - Duration of treatment / exposure:
- continuous
- Observation period (in vivo):
- 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
none to very slight conjunctival reactions including a very slight chemiosis grade 1 a very slight redness (1 -2) are observed in day one and 2 for 2 animals. No other ocular reactions were observered during the study. Mean scores for rednes and chemusis are 0.3 only for day one.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item diammonium 2,2'-dithiodiacetate is not or very slightly irritant when administrated by ocular route to rabbits.
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