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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-04-24 to 1979-05-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize 1965
Version / remarks:
from "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", The Editorial Committee of the Association of Food and Drug Officials of the United States, Business Office: PO Box 1494, Topeka, Kansas; Second Printing 1965, p. 46-48.
GLP compliance:
not specified
Remarks:
pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-2-carbonitrile
EC Number:
202-880-3
EC Name:
Pyridine-2-carbonitrile
Cas Number:
100-70-9
Molecular formula:
C6H4N2
IUPAC Name:
pyridine-2-carbonitrile
Test material form:
solid
Specific details on test material used for the study:
Lot number 5257, order number 02166

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Acclimitization period of 6 weeks. Breeder: Schriever. Body weight 2.5-3.6 kg. Kept in metal boxes (1 rabbit/box) with mesh-wire bottoms in temperature controlled rooms (room temperature 22-23 deg C, relative humidity 47-55%) under artificial light conditions ( 12 hours-day-night-rhythm). Animals had free access to feed (Altromin K) and purified tap water, both provided ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Remarks:
warmed in water bath at 30 deg C to liquefiy
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.5 mL applied to one side, 0.5 mL 0.9 W/V% NaCl-solution (control)
Duration of treatment / exposure:
24 hours
Observation period:
13 days
Number of animals:
3 male, 3 female
Details on study design:
After prty shearing the back on either side of the spine, two 2.5 x 2.5 cm areas were marked. Only the superficial skin of the two cranial areas on either side of the spine was abraded approx. 0.5 cm with a cannula until minor petechial bleedings were observed. Substance and controls were applied to both intact and abraded skin. All treated skin areas were wrapped with a gauze covered by plastic material. The whole trunk was enrolled with an elastic bandage. Gauze was removed after 24 hours. During whole observation period (13 days) skin changes were noted and evaluated every 24 hours, first at 24 hours after application. Animals were sacrificed on day 13 after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
24/48/72 h
Max. score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
Irritation index = 0.27

Any other information on results incl. tables

Sum of all observation points and findings:

 Findings  2 -Cyanopyridine  0.9 W/V% NaCl Solution
 Minor erythema  12  13
 Moderate erythema  2  3
 Not evaluated because of discoloration  2  0
 Minor edema  19  4
 Moderate edema  1  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Draize irritation index = 0.27 (non-irritant by CLP criteria)
Executive summary:

Draize irritation index = 0.27 (non-irritant by CLP criteria)