Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study already available
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guidline study with accepted restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
According to Fed Reg 38 No.187 § 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Propanoic add; propionic acid; CP 66423
- Analytiucal purity: no data
- D-1 Product 5/7/75

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: no data


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 min
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: corrosive with in 1 min. No evaluation of iris, erythema and chemiosis was done therefore
Irritant / corrosive response data:
Immediately after instillation: Severe discomfort with pawing, squealing, and thrashing about the stock
After 1 min: Corrosive
After 14 days: Ulceration

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information