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Toxicological information

Eye irritation

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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:
other: Guideline study in compliance with the GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name in study report: AWA 1351

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:
mean
Remarks:
of each animal
Time point:
other: overall 24-48-72 h
Score:
0.67 - 2.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: fully reversed within 7 days in 5/6 animals. Mean individual score at 24, 48, 72hrs :0.67, 2.33, 2.0, 2.0, 1.33, 2.0
Irritation parameter:
iris score
Basis:
mean
Remarks:
of each animal
Time point:
other: overall 24-48-72 h
Score:
0.33 - 1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Mean individual score at 24, 48, 72 hrs: 0.33, 1.0, 1.0, 0.33, 0.33, 0.33
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of each animal
Time point:
other: overall 24-48-72 h
Score:
1.67 - 2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Mean individual score at 24, 48, 72 hrs: 2.0, 2.0, 2.33, 1.67, 2.33, 2.0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1.67 - 2.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Mean individual score at 24, 48, 72 hrs: 1.67, 2.33, 2.0, 1.67, 2.0, 2.0
Irritant / corrosive response data:
Corneal opacity, noted in 6/6 eyes, persisted to 21 days in one eye rabbit. 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

1.67/2.33/2.0/1.67/2.0/2.0

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 phosphonoacetate is irritating to the eye rabbit and required the classification as Eye Irr. 2 (H319) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R36 according to the Directive 67/548/EEC.
Executive summary:

In an eye irritation study performed similarly to the OECD No. 405 guideline, 0.1 mL of undiluted Triethyl phosphonoacetate was instilled into the right eye of 6 female New Zealand White Rabbits. After the instillation the substance was not remained. 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. 2 (H319)according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R36 according to the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.