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EC number: 800-484-0 | CAS number: 154518-38-4
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 21 August 2012 and 04 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters
- EC Number:
- 800-484-0
- Cas Number:
- 154518-38-4
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters
- Test material form:
- liquid: viscous
- Details on test material:
- Sponsor's identification: Phosphoric acid, C11-14-isoalkyl C13-RICH, CAS 154518-38-4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One New Zealand White (Hsdlf:NZW) strain rabbit was supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animal weighed 2.39 kg and was twelve to twenty weeks old. After an acclimatisation period of at least five days the animal was given a number which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animal was housed in a suspended cage. Free access to mains drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animal was provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated and served as control
- Amount / concentration applied:
- A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye
- Duration of treatment / exposure:
- the eyes were not rinsed after treatment
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Individual scores for ocular irritation are given in Table 1.
Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24, 48, 72 h and 7 d observations and opaque corneal opacity at the 14 d observation. Vascularisation, with a generalised ingrowth of vessels for up to approximately 5 mm, was noted in the treated eye at the 14 d observation. Pannus formation around approximately three quarters of the cornea and extending up to 5 mm towards the centre of the cornea was also noted in the treated eye at the 14 d observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at all subsequent observations.
Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 h observations with moderate conjunctival irritation noted at the 72 h, 7 and 14 d observations.
The reactions noted in the treated eye at the 14 d observation were considered to be indicative of irreversible ocular damage. - Other effects:
- Bodyweight
Individual bodyweights and bodyweight change are given in Table 2.
The animal showed expected gain in bodyweight during the study
Any other information on results incl. tables
Interpretation of Results
If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.
The results were interpreted according to the Globally Harmonised System of Classification and Labelling of Chemicals and Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Dangerous Substances.
Table 1 Individual Scoresfor Ocular Irritation
Rabbit Number and Sex |
72420Male |
|||||
IPR= 2 |
||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
14 Days |
CORNEA |
|
|
|
|
|
|
Degree of Opacity |
1 |
2 |
2 |
2 |
2 |
4VPa |
Area of Cornea Involved |
4 |
4 |
4 |
4 |
4 |
4 |
IRIS |
1 |
1 |
1 |
1 |
1 |
1 |
CONJUNCTIVA |
|
|
|
|
|
|
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
Chemosis |
3 |
3 |
3 |
2 |
2 |
2 |
Discharge |
3 |
3 |
3 |
2 |
1 |
1 |
IPR= Initial pain reaction
V = Vascularisation, with a generalised ingrowth of vessels for approximately up to 4 mm to 5 mm
Pa = Pannus formation around approximately ¾ of the cornea and extending up to 5 mm towards the centre of the cornea
Table 2 Individual Bodyweights and Bodyweight Change
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 14 |
||
72420Male |
2.39 |
2.79 |
0.40 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The test item produced irreversible ocular damage and was considered to be CORROSIVE to the rabbit eye.
The test item was classified as Category 1 (irreversible effects on the eye) according to the Globally Harmonised System of Classification and Labelling of Chemicals.
The test item was also classified as Irreversible effects on the eye (Category 1) according to Regulation (EC) No. 1272/2008. It is reasonable to assume that the Signal Word “Danger” and the Hazard Statement “H318: Causes serious eye damage” are therefore required. - Executive summary:
In a primary eye irritation study according to OECD Guideline 405 (Acute Eye Irritation / Corrosion), adopted 24 April 2002, and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion), 0.1 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) was instilled into the conjunctival sac of the the right eye of one young adult male New Zealand White rabbit. The eye was not washed after treatment. The animal then was observed for 14 days. Irritation was scored by the method of Draize.
Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24, 48, 72 h and 7 d observations and opaque corneal opacity at the 14 d observation. Vascularisation, with a generalised ingrowth of vessels for up to approximately 5 mm, was noted in the treated eye at the 14 d observation. Pannus formation around approximately three quarters of the cornea and extending up to 5 mm towards the centre of the cornea was also noted in the treated eye at the 14 d observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at all subsequent observations.
Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 h observations with moderate conjunctival irritation noted at the 72 h, 7 and 14 d observations.
The reactions noted in the treated eye at the 14 d observation were considered to be indicative of irreversible ocular damage.
In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an eye irritant and produced irreversible effects on the eye (Category 1) based on the criteria of Regulation (EC) No. 1272/2008.
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