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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(2-cyanoethyl)(dodecyl)amino]propanenitrile
EC Number:
605-014-6
Cas Number:
1555-62-0
Molecular formula:
C18H33N3
IUPAC Name:
3-[(2-cyanoethyl)(dodecyl)amino]propanenitrile

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino rabbit
Details on test animals or tissues and environmental conditions:
Species New Zealand albino rabbit
Strain Chbb: NZW (SPF)
Origin Chemical pharmaceutical factory Dr. K. Thomae 88400 Biberach
Number of animals 3
Body weight at start
of the study 3.2 - 3.5 kg
Animal maintenance in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature 20 ±3°C
Relative humidity 50 ±20 %
Lighting time 12 hours daily
Acclimatization 1 week under study conditions
Food ssniff' K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water water from automatic water dispensers, ad libitum
Animal identification numbered ear tags

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eyes served in each case as a control.
Amount / concentration applied:
100 mg per eye
Duration of treatment / exposure:
24h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
100 mg C12-Sternnitril was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance.
At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h, 48h. 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
One and 24 hours after application the conjunctivae of two or one animal showed definitely injected blood vessels. 48 hours after application all irritations reversible.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing of the substance for primary eye irritation according to OECD405 in the rabbit showed, that N,N-Di-(2-cyanoethyl)-dodecylnitril is not irritating to eye.
Executive summary:

Testing of the substance for primary eye irritation according to OECD405 in the rabbit showed, that N,N-Di-(2-cyanoethyl)-dodecylnitril is not irritating to eye.