Registration Dossier

Administrative data

Description of key information

Skin corrosion (in-vitro, Epiderm): Not corrosive.
Skin irritation (in-vitro, Episkin): Not irritating.
Eye irritation (in-vivo): Not irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
other: The study was conducted in compliance with EC, OECD, EPA, and Japanese test guidelines, and in compliance with GLP.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
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. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 44 to 47 weeks
- Weight at study initiation: 3.98 to 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.

IN-LIFE DATES: From: To:
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:
100 mg
Duration of treatment / exposure:
Not applicable. A single intillation 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.
Number of animals or in vitro replicates:
Three females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Consistent with the system described in the EU test method (Commision regulation 440/2008, Part B, method B5).

TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was available.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
3
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.
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The highest total mean score was 2.0 occurring at the one hour observation; accordingly under the criteria Kay and Calandra (1962) Ferrophosphorus (Fe3P) was classified as “practically non-irritating” to the eye. Ferrophosphorus (Fe3P) did not require labelling in accordance with European Commission regulation 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two in-vitro tests were conducted to assess the effect of exposure of Fe3P to the skin. An Epiderm study (Huntingdon Life Sciences, 2010, study number FGE0004) assessed the potential corrosivity of the test material, whereas an Episkin study (Huntingdon Life Sciences, 2011, study number FGE0018) was performed to assess potential skin irritancy. Both studies were conducted according to official OECD test guidelines and in compliance with GLP. The overall conclusion of the two studies was that Fe3P shows no evidence of skin irritation or skin corrosion. On the basis of these two studies, it was concluded that an in-vitro test was not necessary.

An in-vitro study (Bovine Corneal Opacity and Permeability, BCOP, Huntingdon Life Sciences, 2011, study number FGE0017) was conducted to asess the eye irritant potential of Fe3P. The BCOP test was negative (did not indicate any potential to cause eye irritation), but this result alone was not considered sufficient to reach a definitive conclusion on the eye irritant properties of Fe3P, and so an in-vivo test was conducted (Huntingdon Life Sciences, 2012, study number FGE0019). Both studies were conducted according to official test guidelines (OECD and / or EC) and in compliance with GLP. Mild conjunctival redness was seen in one rabbit (out of three) one hour after instillation, but this was fully resolved by the 24-hour observation timepoint, and all treated animals' eyes were considered overtly normal from the 24-hour timepoint onwards. It was concluded that Fe3P is not an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Note that no single study has been selected, as the conclusion as "not corrosive and not irritating" is based on the results of two in-vitro tests (Episkin and Epiderm).

Justification for selection of eye irritation endpoint:
The in-vivo eye irritation test was selected as the Key study as in-vivo data is considered more reliable than in-vitro data.

Justification for classification or non-classification

Fe3P did not demonstrate any irritant properties in any of the skin or eye irritation studies conducted. On this basis it is concluded that Fe3P does not meet the criteria for classification as a skin or eye irritant under either the Classification, Labelling and Packaging (CLP) Regulation, nor under the Dangerous Substances Directive.