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EC number: 939-526-9 | CAS number: 90506-73-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 29/12/2005 to 12/4/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phosphoric acid, mono- and di-C16-18-alkyl esters
- EC Number:
- 291-938-1
- EC Name:
- Phosphoric acid, mono- and di-C16-18-alkyl esters
- Cas Number:
- 90506-73-3
- IUPAC Name:
- 90506-73-3
- Reference substance name:
- Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters
- IUPAC Name:
- Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters
- Details on test material:
- - Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters
- Physical state: white solid pellet
- Storage condition of test material: at rrom temperature (20±5ºC) and in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunícola San Bernardo, S.L
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.4-3.0 Kg
- Housing: individually in stainless steel cages with a grille floor and placed on a rack
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 30-50
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye as a Control
- Amount / concentration applied:
- The quantity of test item to be administered to each animal was 0.1 g.
- Duration of treatment / exposure:
- 1 hour
The remainder of the test item was removed with physiological saline before the first observation. - Observation period (in vivo):
- 1, 24, 48, 72 hours, 7 and 14 days
- Number of animals or in vitro replicates:
- Three female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Hyperaemia)
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.22
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Remarks:
- (Edema)
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.89
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
Body weight in Kg
Animal no. |
Day of treatment |
24h |
48h |
72h |
7days |
14days |
2142 |
3,02 |
3,02 |
3,01 |
3,05 |
3,05 |
3,3 |
903 |
2,36 |
2,39 |
2,41 |
2,44 |
2,56 |
2,75 |
904 |
2,35 |
2,37 |
2,43 |
2,48 |
2,54 |
- |
- : This animal was sacrified 7 days after the administration, as no ocular lesions were recorded
Primary Eye Irritation Test
Primary Eye Irritation Test
Animal no. |
Region of eye |
1h |
24h |
48h |
72h |
7days |
14days |
|
2142 |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Hyperaemia |
2 |
2 |
2 |
2 |
1 |
0 |
|
903 |
Cornea |
Density |
1 |
1 |
1 |
1 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Hyperaemia |
2 |
3 |
3 |
3 |
1 |
0 |
|
904 |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
- |
Iris |
|
0 |
0 |
0 |
0 |
0 |
- |
|
Conjunctivae |
Hyperaemia |
2 |
2 |
2 |
1 |
0 |
- |
|
-: This animal was sacrified 7 days after the administration, as no ocular lesions were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Category 2 Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The alterations induced by the test item were evaluated to the OECD 405 and Method B.5. In view of the results obtained the test item is considered to be non irritant to the eyes based on the criteria set out in Directive 2001/59/EC, Annex VI, and no risk phrase is required. According to CLP, EU GHS (Regulation (EC) No 1272/2008) the test item has to be classified as irritating to eyes (Category 2).
- Executive summary:
In a primary eye irritation study according to the OECD Guideline for the Testing of Chemicals 405 and Commission Directive 2004/73/EC Method B.5, 0.1 g of Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters (100% a.i.) was instilled into the conjunctival sac of the right eye of three female, young adult New Zealand Whit rabbits for 1 hour. The remainder of the test item was removed with physiological saline before the first observation. Animals then were observed for 14 days.
The test item was administered initially to one animal. One hour after the application, diffuse crimson colouring (grade 2) was recorded in the conjunctiva, along with swelling with the lids more than half closed (grade 4). However, during the observations it was difficult to evaluate the hyperaemia due to the swelling of the conjunctiva. The test item was later applied to two more animals. Scattered or diffuse areas of opacity were recorded in the cornea, the details of the iris were clearly visible (grade 1) during the observation performed at one hour following the administration.
The mean values at 24, 48 and 72 hours following administration, for each type of lesion in the three treated animals were:
- Corneal opacity: 0.33
- Lesions in the iris: 0.00
- Hyperaemia: 2.22
- Edema: 0.89
In this study Phosphoric acid, mono- and di- C16-18 (even numbered) alkyl esters are irritating to the rabbit eye.
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