Registration Dossier
Registration Dossier
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EC number: 297-701-9 | CAS number: 93686-48-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following the guideline without any deviation but not performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Phosphorous acid, tri-C12-14-alkyl esters
- EC Number:
- 297-701-9
- EC Name:
- Phosphorous acid, tri-C12-14-alkyl esters
- Cas Number:
- 93686-48-7
- Molecular formula:
- C36H75O3P C38H7903P C40H83O3P C42H87O3P
- IUPAC Name:
- Phosphorous acid, tri-C12-14-alkyl esters
- Test material form:
- other: liquid
- Details on test material:
- purity > 98%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage du Gérome, France
- Age at study initiation: 12 to 13 weeks
- Weight at study initiation: 2,45 to 2,91 kg
- Housing: individual housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15 volumes per hour
- Photoperiod: 12 hrs dark/ 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0,1 mL pure test item - Duration of treatment / exposure:
- One instillation made, then observation during 72h and more if necessary
- Observation period (in vivo):
- Up to 22 day if effects visible
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- Observations at 1, 24, 48 and 72h were made to determine
- conjunctive chemosis
- conjunctive enanthema
- iris lesion
- corneal opacity
The 4 observation times were suumed for the three animals for determining of the maximal ocular irritation index. (OI max)
The scale is then given:
OI max <= 15 : slightly irritant
15< OI max <= 30 : moderate irritant
30< OI max <= 50 : irritant
50< OI max: very irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72h
- Score:
- 9.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritant / corrosive response data:
- Slight conjuntival effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With a maximum mean irritation score of 9.3, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant to eyes according to french protocol and scaling but not classified according to GHS criteria.
- Executive summary:
Phosphorous acid, tri-C12-14-alkyl esters was tested in vivo for eye irritation using OECD 405 test guideline, but the study was not performed under GLP conditions. No deviation to the guideline was noted and the study was considered as reliable but quoted with reliability 2.
Three New Zealand white rabbits were tested with 0,1 mL pure test item and scoring was performed at 1, 24, 48 and 72 hour.
Slight conjuntival effects were noted on 3 animals 1 hour after instillation (enanthema slight to moderate with slight chemosis) and were fully reversible within 48h after treatment. No other clinical or systemic signs were noted.
With a maximum mean irritation score of 9.3, Phosphorous acid, tri-C12-14-alkyl esters was slightly irritant to eyes according to french protocol and scaling but not classified according to GHS criteria.
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