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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:
January 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, performed according to standard method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
EC Number:
259-709-0
EC Name:
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
Cas Number:
55566-30-8
Molecular formula:
C4H12O4P.1/2O4S
IUPAC Name:
tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
Test material form:
other: liquid stored in the dark at ambient temperature.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits, UK
- Age at study initiation: 11 week old
- Weight at study initiation: 2.5 kg
- Housing: individually housed in a metal cage
- Diet / water: free access to tap water and SDS Standard Rabbit Diet.
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity 30-70 %
- Air changes: 19 per hour
- Photoperiod: 12 hr dark / 12 hr artificial light

IN-LIFE DATES: From 30 January to 01 February 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Test animal was instilled with 0.1 mL of test substance. Considering a relative density of 1.392, it corresponds to a dose of 0.14 g of active substance, and 0.10 g of main ingredient, considering the concentration of 75%.

VEHICLE: none (undiluted)
Duration of treatment / exposure:
Single application, not washed
Observation period (in vivo):
60 min, 24 h and 48 hours
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: Draize scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Experiment was teminated 48 hours after instillation.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Experiment was teminated 48 hours after instillation.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Experiment was teminated 48 hours after instillation.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Experiment was teminated 48 hours after instillation.
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.5
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Experiment was teminated 48 hours after instillation.
Irritant / corrosive response data:
After 48 hours of exposure, severe ocular lesions were observed, mainly on conjunctiva, with swelling, necrosis and abundant lachrymal discharge. Lower damages were observed on cornea, with a translucent area and iris slightly obscured.
Other effects:
No data

Any other information on results incl. tables

Table 8.2.1: Ocular reaction elicited by test substance at one animal

Score for the only one animal tested

Cornea

Iris

Conjunctiva

redness

chemosis

Discharge

0 to 4

0 to 2

0 to 3

0 to 4

0 to 3

60 min

0

0

1A

1

1

24 h

3

0

2B

3

2

48 h

2

0

2B

3

3

Average 24h, 48h

2.5

0

2

3

2.5

A Blanching of the eyelids

B Necrosis of the eyelids


Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the test conditions of this study, the test item THPS at 75% in water resulted as corrosive to the rabbit eye. Consequently, the THPS 100% was considered as corrosive to eyes and classified into category 1 (H318) according to EU criteria.
Executive summary:

In an eye irritation study performed according to the US EPA Pesticide Assessment Guidelines, Subdivision F, § 81-4 in compliance with the EPA OPPTS 870.2400, OECD Guidelines 405 and in compliance with the GLP, 0.1 mL of THPS at 75% in water was instilled into the conjunctival sac of the left eye of 1 male New Zealand White rabbit. The eye was not rinsed after administration of the test substance. Ocular reactions were observed approximately 1, 24 and 48 hours after the administration.

The mean individual score were calculated within 2 scoring times (24 and 48 hours).

After 48 hours of exposure, severe ocular lesions were observed, mainly on conjunctiva, with swelling, necrosis and abundant lachrymal discharge. Lower damages were observed on cornea, with a translucent area and iris slightly obscured.

The mean individual scores were 2.5, 0, 2, 3 and 2.5 for corneal opacity, Iris, conjunctivae, chemosis and discharge respectively. These effects were not reversible at 48 hours after application.

Due to the severity of effects, only one animal was treated and the study was terminated 48 h after instillation.

Under the conditions of this test, the test substance was considered to have a severe corrosive action to rabbit eyes. Consequently, the main ingredient THPS 75% (and also THPS 100%) were classified as corrosive to eyes into category 1 (H318) according to the criteria of the CLP Regulation (EC) N°1272/2008.

 

This eye irritation study is classified as acceptable. It satisfies the guideline requirement for an eye irritation study in the rabbits.