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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:
01 December 2011 - 22 December 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted in compliance with EC, OECD, EPA, and Japanese test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008-05-30
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Triiron phosphide
EC Number:
234-682-8
EC Name:
Triiron phosphide
Cas Number:
12023-53-9
Molecular formula:
Fe3P
IUPAC Name:
Iron (3+); phosphorous (3-)
Details on test material:
- Name of test material (as cited in study report): Ferrophosphorous (Fe3P)
- Physical state: Solid
- Analytical purity: Fe 83.39%; P 16.0%
- Lot/batch No.: 1192691
- Expiration date of the lot/batch: 31 December 2011
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 44 - 47 weeks
- Weight at study initiation: 3.98 - 4.52 kg
- Housing: Housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum access to standard laboratory diet.
- Water (e.g. ad libitum): Ad libitum access to drinking water.
- Acclimation period: At least 25 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: No dedicated control animals were used; in each animal the right eye was treated; the left eye remained untreated.
Amount / concentration applied:
a single ocular dose of approximately 100 mg
Duration of treatment / exposure:
Not applicable. A single instillation of the test material was made; eyelids were held together for one second before releasing.
Observation period (in vivo):
72 hours; observations were made 1, 24, 48, and 72 hours after treatment.
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
Three females
Details on study design:
TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation. Each animal was gently restrained. The dose was instilled into the right eye by pulling the lower eyelid away from the eyeball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SERIAL OBSERVATIONS
- Clinical signs:
The behaviour of each rabbit was observed immediately following instillation of the test substance to allow assessment of the initial pain response by the pain scoring system. The animals were returned to their cages and checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed unnoticed.

- Ocular responses:
Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours after treatment, according to the Draize scale. Consistent with the system described in the EU test method (Commision regulation 440/2008, Part B, method B5). The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions.

TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was available.

INTERPRETATION OF RESPONSES
In addition to the classification according to UN GHS (EU CLP) the classification system of Kay and Calandra (1962) was employed for classification of ocular irritants.

TERMINATION
Following completion of the observation period the animals were humanely killed by an intravenous injection of sodium pentobarbital.



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- Injection of the conjunctival blood vessels was apparent in one animal one hour after instillation; no reaction to treatment was evident in the other animals. The treated eyes of all animals were overtly normal 24 hours after instillation
- Instillation of the test substance gave rise to practically no initial pain response.
- Accordingl to the criteria of Kay and Calandra (1962) Ferrophosphorus (Fe3P) was classified as “practically non-irritating” to the eye.
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, in this study and under the experimental conditions reported, Ferrophosphorus (Fe3P) does not require classification and labelling for eye irritation or serious eye damage according to UN GHS and EU CLP.