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 with acceptable restrictions (partly limited documentation, 50 μl instead of 100 μl test substance instilled)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
application volume (50 µL instead of 100 µL)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-dimethylaminopropiononitrile
EC Number:
217-090-4
EC Name:
3-dimethylaminopropiononitrile
Cas Number:
1738-25-6
Molecular formula:
C5H10N2
IUPAC Name:
3-(dimethylamino)propanenitrile
Details on test material:
- Name of test material (as cited in study report): N,N-Dimethyl-amino-propionitril
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one drop of saline into the other eye
Amount / concentration applied:
50 µL
Duration of treatment / exposure:
The eye was left unwashed.
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24- 48 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Smeary layer were observed in both treated eyes until readings after 72 h and 4 d, respectively
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24- 48 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24- 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Applicant's summary and conclusion

Categories Display