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Diss Factsheets

Administrative data

Description of key information

In vivo skin sensitization (guinea pig)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: The optimization test as described by Maurer et al. (1975, 1980).
Version / remarks:
Maurer Th., Thomann P., Weirich E.G., Hess R. The Optimization test in the guinea pig. Agents & Actions 5 (2), 174-179. 1975.
Maurer Th., Weirich E.G. and Hess R. The Optimization test in the guinea pig in other predictive sensitization methods. Toxicology, 15, 163-171, 1980
Deviations:
not specified
Principles of method if other than guideline:
The optimization test was used, an intracutaneous sensitization procedure exceeding the sensitivity of the method recommended in the "Appraisal of the Safety of
Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
yes (incl. QA statement)
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
Study was conducted prior to REACH regulation.
Specific details on test material used for the study:
TEST MATERIAL (as described in study report): TK 12 184

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 312-187
Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: In house
- Weight at study initiation: 450 - 555 grams
- Housing: individually in Macrolon cages, type 3
- Diet: Standard guinea pig pellets - NAFAG, No. 830, Gossau SG, Switzerland
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2 deg C
- Humidity (%): 55 +10 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
other: propylene glycol 50% : saline 50% (week 1); mixture of saline with complete Bacto Adjuvant, 1 : 1 (weeks 2 and 3).
Concentration / amount:
0.1%
Day(s)/duration:
20 days - injections every other day (a total of 10 injections)
Adequacy of induction:
not specified
No.:
#1
Route:
intradermal
Vehicle:
other: propylene glycol 50% / saline 50%
Concentration / amount:
0.1 %
Day(s)/duration:
During week 6
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
10%
Day(s)/duration:
During week 8
Adequacy of challenge:
other: a subirritant dose
No. of animals per dose:
20
Details on study design:
Testing procedure
During the induction period the animals received injections every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 12 184 in propylene glycol 50 % / saline 50 %. One control group was treated with the vehicle alone ("negative control").
On the first day of week 1, two injections of 0.1 ml were administered into the shaven skin of the right flank and while on the following days a single intracutaneous injection was given into the flank.
During the second and third week of the induction period the test material was incorporated in a mixture of saline with complete Bacto Adjuvant (saline : adjuvant 1:1).
During week 6 a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of TK 12 184 in propylene glycol 50 % / saline 50 % 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 the "reaction volume" was obtained {in µ1) 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 allergic 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”).
During week 8 a subirritant dose (10 % TK 12 184 in vaseline) of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The skin irritation was recorded according to Draize (described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959 of the US Association of Food and Drug Officials (AFDO) 24 hours after removal of the dressings.
Challenge controls:
Treated with vehicle alone
Positive control substance(s):
no
Reading:
other: intradermal
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
1
Total no. in group:
20
Reading:
other: epicutaneous
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
20
Reading:
other: intradermal
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% concentration
No. with + reactions:
11
Total no. in group:
20
Reading:
other: epicutaneous
Hours after challenge:
24
Group:
test chemical
Dose level:
10% concentration
No. with + reactions:
8
Total no. in group:
20
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under the conditions of this test, TK 12 184 is considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In an in vivo skin sensitization study conducted in guinea pigs by repeated intradermal injection (0.1% concentration) according to Maurer optimisation test procedures, positive skin reactions were observed in 11 of 20 animals following challenge doses administered by intradermal injection, and in 8 of 20 animals following re-challenge by occlusive epicutaneous patches.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, TGEPO is classified as a Category 1 skin sensitiser.