Registration Dossier

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:
03/06/2003-24/06/2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted guidelines with some limitations.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
Environmental parameters: A relative humidity of 72% was recorded in the course of this study rather than 70% (maximum limit) as stated in the experimental protocol,
A temperature of 25°C was recorded in the course of this study rather than 23°C (maximum limit) as stated in the experimental protocol.

These deviations did not in any event affect the performance and the results of this study.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NICKEL NITRATE CRYST 6H20
- Physical state: solid powder
- Lot/batch No.: 8115 TQ
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMAL
- Source: Elevage de Gérome (Quartier Labaste - 40260 Linxe)
- Weight at study initiation: 2.19-2.23 kg
- Housing: individual cage
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-25
- Humidity (%): 58-72

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of same animals
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
not reported
Observation period (in vivo):
1, 24, and 48 hours
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Maxiumum Eye Irritation Index (I.O. Max)
Basis:
animal: A5362
Time point:
other: Through day 22
Score:
>= 13 - <= 82
Max. score:
82
Reversibility:
not fully reversible within: D21 (end of observation period)
Irritation parameter:
cornea opacity score
Basis:
animal: A5362
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
iris score
Basis:
animal: A5362
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
enanthema (rash)
Basis:
animal: A5362
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
chemosis score
Basis:
animal: A5362
Time point:
24 h
Score:
3
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
chemosis score
Basis:
animal: A5362
Time point:
48 h
Score:
3
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
chemosis score
Basis:
animal: A5362
Time point:
72 h
Score:
3
Reversibility:
not fully reversible within: 22 days
Irritant / corrosive response data:
Moderate to significant eye effects that were partially reversible were noted, namely:
- at the level of the conjunctiva: a moderate enanthema noted 1 hour after the instillation of the product and still noted at the end of the observation period (D21) (mild intensity), associated with a significant chemosis, noted 1 hour after the instillation of the product and still noted at the end of the observation period (D21) (moderate intensity),
- at the level of the cornea: a moderate opacity, noted 24 hours after the instillation of the product and still noted at the end of the observation period (D21) (mild intensity),
- at the level of the iris: mild congestion was noted from the 1st to the 5th day, followed significant congestion from the 6th to the 17th day of the study.
Furthermore, these effects are accompanied by a purulent secretion requiring rinsing with physiological solution from the 2nd to 17th day of the study.

Applicant's summary and conclusion