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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The criteria used to assess the effects and the results are not detailed enough to conclude on the classification.

Data source

Reference
Reference Type:
publication
Title:
Chemical burns of the rabbit cornea
Author:
Carpenter CP, Smyth HF
Year:
1946
Bibliographic source:
American Journal of ophthalmology 29: 1363-1372

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline available at the date of the study. However principles of the method used are similar to the current ones except regarding the coring system.
GLP compliance:
no
Remarks:
Study made before the GLP creation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
other: see below
Controls:
not specified
Amount / concentration applied:
0.005 mL undiluted
Duration of treatment / exposure:
18 to 24 hours
Observation period (in vivo):
only 24 hours
Number of animals or in vitro replicates:
No precise data, "usually 5" is mentioned in the publication
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data


SCORING SYSTEM:
Scoring of the injury:
Symptom visible before fluorescein staining:
Cornea dull 2 points
Cornea opaque, less than half of the area 4 points
Cornea opaque, more than half of the area 6 points maximum 6
Keratoconus maximum 6
Iritis, slight internal congestion 1 point
Iritis, marked internal congestion 2 points, maximum 2

Symptom visible after fluorescein staining:
Necrosis on less than 5% of cornea 1 point
Necrosis on 5% to 12% of cornea 2 points
Necrosis on 13% to 37% of cornea 3 points
Necrosis on 38% to 62% of cornea 4 points
Necrosis on 63% to 87% of cornea 5 points
Necrosis on 88% to 100% of cornea 6 points, maximum 6
Total 20
Here are the individual numerical scores. The mean is calculated to obtain the score of the injury caused by the treatment. A level of 5.0 is considered as severe injury.

Categories used to rate the products:
1 to 10.
cat 8 corresponds to excess of 5% solution gives injury of up to 5.0 points.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Irritant / corrosive response data:
The category for DES is 5: 0.005 ml undiluted gives injury of up to 5.0 points.

Applicant's summary and conclusion

Interpretation of results:
other: 0.005 mL undiluted gives injury of up to 5.0 points.
Remarks:
Criteria used for interpretation of results: other: Carpenter & Smyth, 1946
Conclusions:
According to the criteria of the authors, DES can be considered to cause injuries to the rabbit eye.
Executive summary:

Eye irritation of DES has been assessed in the rabbit with application of 0.005 mL of undiluted substance.

The scoring system and the interpretation of the results are different from the current guideline and no clear conclusion can be drawn from these results. The grade for DES is 5 on a scale of 10.