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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1979 - January 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Study carried out before publication of OECD guidelines or availablilty of LLNA test methods.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was carried out before availability of LLNA methodology and before publication of relevant OEC test guidelines.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[[3-(dimethylamino)propyl]amino]propiononitrile
EC Number:
274-159-1
EC Name:
3-[[3-(dimethylamino)propyl]amino]propiononitrile
Cas Number:
69852-45-5
Molecular formula:
C8H17N3
IUPAC Name:
3-{[3-(dimethylamino)propyl]amino}propanenitrile
impurity 1
Chemical structure
Reference substance name:
3,3'-[[3-(dimethylamino)propyl]imino]bispropiononitrile
EC Number:
275-331-9
EC Name:
3,3'-[[3-(dimethylamino)propyl]imino]bispropiononitrile
Cas Number:
71326-27-7
Molecular formula:
C11H20N4
IUPAC Name:
3,3'-{[3-(dimethylamino)propyl]imino}dipropanenitrile
Test material form:
liquid
Remarks:
colorless
Specific details on test material used for the study:
Liquid
Batch No. Sdg. 807701

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright white strain bred at Bantin and Kingman Ltd. Grimston, Huil, England and weighing between 375 to 520 grams. The animals were housed individually in Macroion cages, type 3, assigned to the different groups by means of random numbers generated by the random number generator incorporated in the Hewlett-Packard desk computer, identified with individual ear tags, kept at a constant room temperature of 22 + 2° C, at a relative humidity of 55 + 10 % and on a 10 hours light cycle day. The animals received adlibitum Standard guinea pig pellets - NAFAG, No. 830, Gossau SG - and water. Bodyweights were recorded immediately before starting the experiment (control values) and at termination of the study.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1%
Day(s)/duration:
14 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.1%
0.1ml
Day(s)/duration:
10
Adequacy of challenge:
not specified
No. of animals per dose:
10 male, 10 female
Details on study design:
During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 12271 in physiological saline. One control group was treated with the vehicle alone ("negative control").

On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.

During the second and third week. of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant2 (vehicle : adjuvant = 1 : 1 ) .

Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of TK 12271 in physiological saline was administered into the skin of the left flank.

Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.

The two largest perpendicular diameters (in mm) and the increase in the skin- fold thickness (in mm) were measured and by multiplication of these values "reaction volume was obtained (in yl) for each reading from each animal. The mean volume plus one Standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergie reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control")3.

Ten days after the intracutaneous challenge injection a subirritant dose of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of TK 12271.TK 12271 was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.