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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline 437 (Bovine Corneal Opacity and Permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tartaric acid
- Substance type: fine powder
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: B10x 1914
- Storage condition of test material: at room temperature, protected from light

Test animals / tissue source

Species:
other: Bovine
Strain:
not specified

Test system

Vehicle:
other: 0.9% NaCl
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μl
- Concentration (if solution): 20 % concentration
Duration of treatment / exposure:
4 hours ± 5 minutues
Observation period (in vivo):
after 90 minutues, its optical density at 490 nm was determine, using a spectrophotometer
Number of animals or in vitro replicates:
3 corneas for the test item, 3 corneas as negative controls treated with physiological saline 0.9 % NaCl, 3 corneas as positive control treated with imidazole 20% in physiological saline 0.9% NaCl .
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the opacity measurement the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 ml of a 5 mg/ml sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ℃ 1 ℃.
- Time after start of exposure: 4 hours ℃ 5 minutes

SCORING SYSTEM: see table in "any other information on materials and methods incl. tables"

TOOL USED TO ASSESS SCORE: spectrophotometer

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
ca. 118.765
Reversibility:
not specified
Irritant / corrosive response data:
The test item was diluted to 20% in 0.9% NaCl. The following mean in vitro score was calculated: 118.765. Therefore the test item was classified as very severe irritant. The in vitro score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid. See table 1.

Any other information on results incl. tables

TABLE 1. in vitro score

Cornea-No.

Test Item

Corrected opacity value

Corrected OD490 value

In vitroScore

1

Negative Control

-2

0.120

1.767

2

0

0.170

3

-2

0.330

MV

-1.333

0.207

1

Positive Control Imidazole

165.333

2.086

196.017

2

180.333

2.094

3

148.333

2.089

MV

164.667

2.090

1

Tartaric acid

127.33

-0.025

118.765

2

111.33

-0.018

3

118.33

-0.005

MV

119.000

-0.016

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
According to the evaluation criteria the test item Tartaric Acid is classified as very severe eye irritant.
Executive summary:

The eye irritancy potential of Tartaric Acid was investigated in the bovine corneal opacity and permeability assay. Preparation of the test item: 20% dilution in 0.9% NaCl. Mean in vitro score: 118.765. Therefore tartaric acid is classified as very severe eye irritant. The in vitro score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.