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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:
17 - 20 Nov 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance kaolin (CAS 1332-58-7). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Surround (R) WP Crop Protectant
- PSL Reference number E01110-1D
- Physical state / appearance: white powder
- Composition of test material, percentage of components: kaolin - 95%, others - 5%
- Lot/batch No.: Lot #02140
- Expiration date of the lot/batch: not applicable
- Stability: Test substance is expected to be stable for the duration of testing
- Storage condition of test material: at room temperature
- Other: solubility: insoluble

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: young adult
- Housing: singly housed in suspended stainless steel caging with mesh floors (which conform to the size recommendations in the Guide for the Care and Use of Laboratory Animals DHEW (NIH)
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 14 days
- Contaminants: Analyses of the food and water are conducted at least once a year

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye of each rabbit remained untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.04 - 0.05 g)


Duration of treatment / exposure:
without washing-off
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not removed

SCORING SYSTEM: in accordance with Draize (Draize et al., 1944); the fluorescein dye evaluation procedure was used at 24 hours to verify the absence of corneal damage (Scale for Scoring Ocular Lesions)

TOOL USED TO ASSESS SCORE: high-intensity white light (Mag light), fluorescein (Blak-Ray Lamp compact 4-watt UV Lamp)

The test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance.
Ocular irritation was evaluated at 1, 24, 48 and 72 hours post-instillation.
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra (1962).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritant / corrosive response data:
All animals appeared active and healthy. Apart from the eye irritation, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. One hour following test substance instillation, all three treated eyes exhibited slight conjunctivitis. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 48 hours.

Any other information on results incl. tables

Table 1: Individual scores for ocular irritation

 

Rabbit No. 1 (female)

Rabbit No. 2 (male)

Rabbit No. 3 (female)

time post-installation [hours]

1

24

48

72

1

24

48

72

1

24

48

72

Cornea

Opacity

0

0

0

0

0

0

0

0

0

0

0

0

Iris

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae Redness

1

1

0

0

1

0

0

0

1

0

0

0

Conjunctivae

Chemosis

1

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

Discharge

1

1

0

0

1

0

0

0

1

1

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information