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EC number: 212-757-6 | CAS number: 867-13-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 15 September 1992 to 4 November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in compliance with international standard guidelines under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triethyl phosphonoacetate
- EC Number:
- 212-757-6
- EC Name:
- Triethyl phosphonoacetate
- Cas Number:
- 867-13-0
- Molecular formula:
- C8H17O5P
- IUPAC Name:
- ethyl 2-(diethoxyphosphoryl)acetate
- Test material form:
- 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: Ace Animals
- Age at study initiation: no data
- Weight at study initiation: 2.7-3.1 kg
- Fasting period before study: none
- Housing: 2/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but conditions not specified
- Humidity (%): no data
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: from 5 October 1992 to 26 October 1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 2 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 d
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- Corneal opacity, noted in 6/6 eyes, persisted to 21 days in the eye of 1/6 rabbits. Iritis and moderate conjunctival irritation, noted in 6/6 eyes, cleared by day 14. See details in Table 7.3.2/1.
- Other effects:
- No abnormal systemic signs noted
Any other information on results incl. tables
Table 7.3.2/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.
Score at time point / Reversibility | Cornea | Iris | Conjunctivae | Chemosis |
Max. score: 4 | Max. score: 2 | Max. score: 3 | Max. score: 4 | |
24 h | 2/2/2/2/2/2 | 1/1/1/1/0/1 | 3/2/3/2/2/2 | 2/2/2/3/2/2 |
48 h | 0/2/2/2/2/2 | 0/1/1/0/0/0 | 2/2/2/2/3/2 | 2/3/2/2/2/2 |
72 h | 0/3/2/2/0/2 | 0/1/1/0/0/0 | 1/2/2/1/2/2 | 1/3/2/0/2/2 |
7 days | 0/3/0/0/0/0 | 0/1/0/0/0/0 | 0/2/0/0/1/0 | 0/3/0/0/1/0 |
14 days | 0/2/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
21 days | 0/2/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
Average 24h, 48h, 72h | 0.67/2.33/2.0/ 2.0/1.33/2.0 | 0.33/1.0/1.0/0.33/0.33/0.33 | 2.0/2.0/2.33/1.67/2.33/2.0 | 1.67/2.67/2.0/1.67/2.0/2.0 |
Reversibility*) | nc | c | c | c |
Average time (day) for reversion | N/A | 14 | 14 | 14 |
*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, Triethyl phosphono acetate is irritating to the eye rabbit and required the classification as Eye Irr. 2A (H319) according to the Regulation (EC) 1272/2008 (CLP).
- Executive summary:
In an eye irritation study performed similarly to the OECD 405 guideline, 0.1 mL of undiluted Triethyl phosphono acetate was instilled into the right eye of 6 female New Zealand White Rabbits. After the instillation the substance did not remain. Animals were then observed for 21 days for eye edema and erythema of the conjunctive, corneal opacity and iris lesion.
Eye irritation was assessed and scored according to the Draize scale at 24, 48 and 72 hrs after the instillation of the substance and then at days 7, 14 and 21. The mean individual score were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean individual scores were for 1.67/2.33/2.0/1.67/2.0/2.0 chemosis, 0.33/1.0/1.0/0.33/0.33/0.33 for iris lesion, 2.0/2.0/2.33/1.67/2.33/2.0 for conjunctival erythema, and 0.67/2.33/2.0/ 2.0/1.33/2.0 for corneal opacity.
Effects on the iris and the conjunctivae (redness and chemosis) were fully reversible in all animals within 14 days. However, corneal opacity persisted in one animal until day 21 whereas in all other animals (5/6) the effect fully reversed within 7 days.
Under the test conditions,Triethyl phosphonoacetate is considered as irritating to the eye rabbit and is therefore classified as Eye Irr. 2A (H319) according to the Regulation (EC) 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for the eye irritation endpoint.
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