Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, 0.05 mL application amount)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, application amount 0.05 mL)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Suberonitrile
EC Number:
211-089-2
EC Name:
Suberonitrile
Cas Number:
629-40-3
Molecular formula:
C8H12N2
IUPAC Name:
suberonitrile
Details on test material:
- Name of test substance (as cited in study report): Korksaeuredinitril
- Analytical purity: no data
- Substance No.: XIII/213
- Sample No.: C 520/326
- Physical state: liquid
- Density: 0.942 g/mL

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.18 kg and 2.27 kg

No additional information reported.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of the same animal served as control
Amount / concentration applied:
0.05 mL
Duration of treatment / exposure:
one single application
Observation period (in vivo):
2 days reported in the raw data (8 days in study report)
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean over 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean over 24 and 48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean over 24 and 48 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: 1 h after application: score = 1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean over 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 1 h after application: score = 1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information

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