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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-02-23 to 1996-06-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Testing was conducted prior to the adoption of the the original Test Guideline (TG) for the determination of skin sensitization in the mouse, the Local Lymph Node Assay (LLNA; TG 429) in 2002

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
421-300-1
EC Name:
-
Cas Number:
138564-59-7
Molecular formula:
C12H9N3O2S
IUPAC Name:
5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile
Test material form:
solid: particulate/powder
Details on test material:
97.7%
Item code QA405K
Lilly lot no: 356MO1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and 356M01
- Purity test date: 1995-11-30

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature in the dark.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Suspended in polyethylene glycol by mixing onan orbital shaker for 1h prior to dosing.

FORM AS APPLIED IN THE TEST (if different from that of starting material)
0 and 75% concentrations in polyethylene glycol

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: <1 year old
- Weight at study initiation: 288-339 g
- Housing: Aluminium cages ( dimensions 48 x 61 x 25 cm) with a grid floor. Beneath each cage was a suspended tray lined with absorbent paper. The dose ranging animals were housed 4 to a cage and the main study animals 5 to a cage.
- Diet (e.g. ad libitum): Guinea Pig Diet FDl, supplied by Special Diets Services Ltd, 1 Stepfield, Witham, Essex, CMS 3AD was available ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
- Indication of any skin lesions: None

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
polyethylene glycol
Concentration / amount:
75%
Day(s)/duration:
3 weeks for 6 h a day
Adequacy of induction:
not specified
Route:
epicutaneous, semiocclusive
Vehicle:
polyethylene glycol
Concentration / amount:
0 %
Day(s)/duration:
3 weeks for 6 h a day
Adequacy of induction:
not specified
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
0%
Day(s)/duration:
6 h once
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
75%
Day(s)/duration:
6 h once
Adequacy of challenge:
not specified
No. of animals per dose:
20 per test group
10 per control group
Challenge controls:
The challenge control was conducted at the same site, concentration, using the same vehicle, on guinea pigs who had not undergone the induction procedure.
Positive control substance(s):
yes

Results and discussion

Positive control results:
The most recent positive control was completed on 10 April 1996. Following challenge at a concentration of 50% HCA in acetone/PEG 400 (70:30 v/v), twelve (60%) of the test group animals and no (0%) control group animals showed a positive response. These results demonstrate the ability of the methodology to identify a mild/moderate sensitizer.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
12
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
1
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
1
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
1
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
1
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This study found the test substance to be non-sensitizing according to GHS criteria.
Executive summary:

Testing was carried out in accordance with OECD Guideline No. 406 and EEC guidelines, Annex V Method B6. The delayed contact hypersensitivity of the tet material was investigated by means of a Buehler Sensitisation Test in guinea pigs. The study had originally been planned as a Magnusson-Kligman Maximisation Test in Guinea Pigs, however the test material proved severely irritant when dosed intradermally. The main study design was therefore amended to that of a Buehler test, as recommended by the Regulatory Authorities in such circumstances.

The Buehler Test comprised 2 procedures: an induction and a challenge procedure. The induction procedure consisted fo topical exposure to the test material on one day each week for three consecutive weeks and this was followed by a topical challenge exposure to the test material conducted two weeks after the final induction application.

Two groups of animals were used in the study, a test and a control group containing 20 and 10 animals, respectively. During the induction procedure the test group was exposed to 75% Intermediate 290437. The control group were exposed to vehicle only during this procedure. All the animals were then challenged with 75% Intermediate 290437.

At challenge with 75% Intermediate 290437, (0%) positive responses were noted in the test group and no (0%) positive responses were noted in the control group.

Under the conditions of the study, Intermediate 290437 is considered not to be a sensitiser in guinea pigs.