Registration Dossier
Registration Dossier
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EC number: 253-760-2 | CAS number: 38051-10-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 - 5 December 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- EC Number:
- 253-760-2
- EC Name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- Cas Number:
- 38051-10-4
- Molecular formula:
- C13H24Cl6O8P2
- IUPAC Name:
- 2,2-bis(chloromethyl)propane-1,3-diyl tetrakis(2-chloroethyl) bis(phosphate)
- Details on test material:
- Product name: Amgard V6
Appearance: very pale straw coloured viscous liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.47 - 2.73 kg
- Housing: suspended metal cages
- Diet: ad libitum (STANRAB SQC)
- Water: ad libitum
- Acclimation period: minimum 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 50 - 59
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye of each rabbit remained untreated and was used for control purposes
- Amount / concentration applied:
- 0.1 mL of test material
- Observation period (in vivo):
- 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- One rabbit was initially treated. After consideration of the ocular responses, two additional animals were treated.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM: Draize Scale and modified Kay and Clandria Scheme. Additional according to 91/325/EEC.
TOOL USED TO ASSESS SCORE: standard ophthalmoscope with light source.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 48H
- Remarks on result:
- other: Data from study Cuthbert JA Jackson D(1990). See supportive study attached
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 48H
- Remarks on result:
- other: Data from study Cuthbert JA Jackson D(1990). See supportive study attached
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- not fully reversible within: 48h
- Remarks on result:
- other: Data from study Cuthbert JA Jackson D(1990). See supportive study attached
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 Hour after treatment
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 Hour after treatment
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 hour after treatment
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Irritant / corrosive response data:
- - Minimal conjunctival redness (score 1) was noted in all treated animals 1 hour after treatment
- All treated eyes appeared normal after 24, 48 and 72 hours after treatment
- No conreal or iridial effects were noted during the study
- Maximum group mean score was 2.0; leading to classification as Non-irritating (class 1 on a scale from 1 to 8, according to modified Kay and Calandra classification system)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritant to rabbit eye under the conditions of this study.
- Executive summary:
In a primary eye irritation study, according to OECD Guideline No.405, 0.1 mL of undiluted 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) was instilled into the conjunctival sac of 3 New Zealand white rabbits (1 female, 2 male rabbits used). Animals then were observed for 3 days. Irritation was scored by the method of Draize, scale for scoring ocular irritation. The test material was not irritant to rabbit eye under the conditions of this study.
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