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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:
key study
Study period:
December 1998 to November 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion). Reliability of 2 due to use of study for read across.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Nickel sulphate hexahydrate
IUPAC Name:
Nickel sulphate hexahydrate
Constituent 2
Reference substance name:
10101-97-0
EC Number:
600-152-3
Cas Number:
10101-97-0
IUPAC Name:
10101-97-0
Details on test material:
- Name of test material (as cited in study report): nickel sulfate hexahydrate (10101-97-0)
- Molecular formula (if other than submission substance): NiO4S.6H2O
- Molecular weight (if other than submission substance): 333.083
- Smiles notation (if other than submission substance): S(=O)(=O)([O-])[O-].[Ni+2]
- InChl (if other than submission substance): InChI=1/Ni.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
- Physical State: blue-green crystalline powder
- Lot No.: 08516TQ
- Storage: Stored at room temperature
- Other details not reported or not applicable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA.
- Age at study initiation: Adult
- Weight at study initiation: not reported
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 19-50
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

VEHICLE: none reported
Duration of treatment / exposure:
168 hours
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3
Details on study design:
Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury. Three rabbits (one  
male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed. The test article was instilled into the conjunctival 
sac of the right eye of each animal, a minimum of 1 hour after preliminary examination. Following instillation, the eyelids were gently held together 
for one second to limit test article loss. The untreated left eye of each animal served as the control. Animals were examined twice daily. Body weights were  measured prior to dosing. All animals were sacrificed at the end of the  study duration. No necropsy examinations were performed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7 days after dosing. Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).

TOOL USED TO ASSESS SCORE:
fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
edema (chemosis)
Basis:
mean
Time point:
other: 48 hours
Score:
0.44
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Exposure to the test substance produced iritis in 3/3 test eyes at the 1-hour scoring interval.  The iritis resolved completely by 48 hours.
Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval. Conjunctival irritation resolved completely in all test eyes by study day 7.  
Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Exposure to the test substance produced iritis in 3/3 test eyes at the 1-hour scoring interval, which completely by 48 hours. Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval. Conjunctival irritation resolved completely in all test eyes by study day 7. No other effects were observed. Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit but not sufficient to classify as an eye irritant in the European Union.

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