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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:
16 June 2010 - 17 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 437 (adopted 7 September 2009)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: white powder
- Purity test date: 11 March 2010
- Expiration date of the lot/batch: end of March 2012
- Stability under test conditions: confirmed
- Storage condition of test material: <30°C

Test animals / tissue source

Species:
other: in vitro study using excised bovine corneas
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
not applicable

Test system

Vehicle:
other: 0.9% sodium chloride solution
Controls:
other: 3 corneas used with negative control (0.9% sodium chloride solution) and 3 with a positive control (20% w/v imidazole).
Amount / concentration applied:
750 µL
Duration of treatment / exposure:
Assessment of corrosivity/severe irritation: 4 hour incubation. Permeability endpoint additional incubation for 1.5 hours ± 5 minutes
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
3 corneas per treatment (test, positive and negative control)

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
24.69
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: did not cause corrosion or severe irritation

Any other information on results incl. tables

Corneal opacity, permeability and in vitro irritation scores

Chemical

mean corneal opacity

Permeability

IVS score

mean negative control corrected optical density

average group corrected optical density

 

test substance

-1.7

n/a

1.7593

24.69

negative control

0.0

0.0240

0.0000

0.00

positive control

72.7

n/a

-0.0053

72.62

Applicant's summary and conclusion

Interpretation of results:
other: does not cause corrosion or severe irritation
Remarks:
Criteria used for interpretation of results: other: OECD
Conclusions:
The substance was considered not to cause corrosion or severe irritation to the eye under the conditions of the assay.
Executive summary:

A volume of 750 µL of salicylamide formulation, negative control (0.9% sodium chloride solution) or positive control (20% w/v imidazole) was applied to each of three excised bovine corneas followed by a 4 hour incubation at 32°C. After this incubation, each cornea was washed with media containing phenol red followed by media without phenol red, the opacities measured and then the anterior chamber emptied. For the permeability endpoint, sodium fluorescein solution was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and three 200 μL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers.

The salicylamide formulation produced an In Vitro Irritation Score of 24.69.

The positive control article produced an In Vitro Irritation Score of 72.62.

Salicylamide was considered not to cause corrosion or severe irritation to the eye under the conditions of the assay.