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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
03.01.2003 to 26.01.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. Study not directly relevant based on the low pH of the submission substance and the low concentration tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Laboratory grade ferrous sulphate heptahydrate
- Substance type: Iron salt
- Physical state: Green solid
- Analytical purity: 99.5 %
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: 644G
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Ambient temperature in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Limited, Kent, UK
- Age at study initiation: 'Young'
- Weight at study initiation: 2327-3295 g
- Housing: Individually in 'cages suitable for animals of this strain'
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3
- Humidity (%): 30-70
- Air changes (per hr): Minimum of 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 06.01.2003 To: 26.01.2003

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): as a 249 mg/l solution in water, equivalent to a 5% solution of Fe, which is typically the strongest solution used commercially.
Duration of treatment / exposure:
Eyes not rinsed so no truncation of exposure occurred.
Observation period (in vivo):
Three days
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Draize scale


TOOL USED TO ASSESS SCORE: fluorescein staining

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: one hour
Score:
4
Max. score:
110
Reversibility:
fully reversible within: three days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: one day
Score:
3.3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: two days
Score:
2
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: three days
Score:
0
Max. score:
110
Irritant / corrosive response data:
There were no corneal or iridial effects. Conjunctival effects were observed in all animals for up to two days and consisted of slight redness and slight chemosis. There were no other signs of irritation. Mean scores one hour, 24 hours or 48 hours after dosing were 4, 3.3 and 2. By the 72 hour assessment reactions had all resolved and the mean score was zero.
Other effects:
There were no signs of systemic toxicity. Instillation caused practically no or only slight initial pain.

Any other information on results incl. tables

Mild irritation, practically no initial pain response and all clear within 48 hours.
Scores were as follows:
Opacity. 0.0, 0.0 and 0.0
Iritis. 0.0, 0.0 and 0.0
Redness. 0.7, 0.7 and 0.3
Chemosis. 0.7, 0.0 and 0.3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Iron sulfate heptahydrate (5% iron) was not irritating to the eyes of rabbits.

The EFSA conclusion (EFSA Journal 2012;10(1):2521; CONCLUSION ON PESTICIDE PEER REVIEW, Conclusion on the peer review of the pe
sticide risk assessment of the active substance iron sulfate

European Food Safety Authority) for iron sulphate irritancy was based on human data and the precautionary principle and on physical properties, and only one old reference with other citations in literature as moderate irritant without further evidence . For eye irritancy EFSA concluded Irritant (R36) (human data – precautionary, based on physical properties, only one old reference).
Aqueous solutions of iron trinitrate have low pH values, for a 5% aqueous solution of iron trinitrate nonahydrate the pH range was 1.5-2.5 and typically effective values were <2.0 (pH 1.5-1.7). These values would indicate potential corrosive properties for iron trinitrate and read across from iron sulphate (based on the results presented in this study summary) is not considered appropriate for assessment of iron trinitrate irritation.

Executive summary:

0.1 ml of ferrous sulphate heptahydrate solution, a 249 mg/l solution in water, equivalent to a 5% solution of Fe, which is typically the strongest solution used commercially, was instilled into one eye of each of three rabbits. The treated eyes were asessed for changes over the following 72 hours and group mean scores calculated for standard eye irritation parameters. Conjunctival reactions resolved within 72 hours and no corneal or iridial changes were apparent. Iron sulfate heptahydrate (5% iron) was not irritating to the eyes of rabbits.