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Diss Factsheets

Administrative data

Description of key information

non-sensitising, guinea pig, OECD 406, Buehler test, Ebert 1996

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:
1995-08-21 to 1995-12-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD guideline
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:
Currently no LLNA study is available for assessment. The Guinea pig Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Dunkin Hartley, Pirbright White HSD/Win:DH (SPF)
- Age at study initiation: young adult
- Weight at study initiation: 310 - 381 g
- Housing: conventional, up to 5 animals/Macrolon cage type IV
- Diet: ad libitum, Ssniff G 4 Alleindiaet fuer Meerschweinchen
- Water: communal drinking water ad libitum
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 1995-08-21 To: 1995-12-29
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
vaseline
Concentration / amount:
Pretest: 2.5, 10, 25, 50 % (w/w)
Induction phases I-III: 50 % (w/w)
Challenge: 50 % (w/w)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
vaseline
Concentration / amount:
Pretest: 2.5, 10, 25, 50 % (w/w)
Induction phases I-III: 50 % (w/w)
Challenge: 50 % (w/w)
No. of animals per dose:
Pretest: 3 animals
Main test: 20 animals
Determination of challenge concentration: 3 animals each, pretest and week 4
Control to main test: 10 animals
Details on study design:
RANGE FINDING TESTS:
Formulation of the solid test material: Concentrations of 10, 50, and 70% (w/w) of the finely ground powder in petrolatum (vaseline) were tested, and 50% was determined to be the highest concentration that ensured a good skin contact.
Tolerability: Application of the test substance in petrolatum (0.5 g of mixture, concentrations 2.5, 10, 25, 50 %) to the shaved flanks of 3 animals, (4 gauze patches per animal, area 2x2cm each), with occlusive dressing, for 6 hours. Recording of skin reactions at 30 and 54 hours after the start of the application.
Similar Range finder during the 4th week of the experiment, with 3 untreated animals, to account for changes in skin sensitivity due to increased weight and age.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: days 0, 7, and 14
- Duration: 28 days
- Concentrations: 50% test substance in petrolatum, 0.5 g of the mixture

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals
- Control group: 10 animals
- Site: right flank, posterior
- Vehicle patch site: right flank, anterior
- Concentrations: 50% test substance in petrolatum, 0.5 g of the mixture
- Evaluation (hr after challenge): 30 and 54

OTHER:
Challenge controls:
10 animals exposed to the pure vehicle 3 times during the induction period, challenged in the same way as the exposure group (50% w/w test material in petrolatum)
Positive control substance(s):
yes
Remarks:
Strain sensitivity to 2-mercaptobenzothiazole tested 1995-06-22
Positive control results:
Sensitivity test HS-95/MCPT of the guinea pig strain Dunkin Hartley, Pirbright White (DHPW), performed 1995-05-22 to 1995-06-22, with 2-mercaptobenzothiazole (50% in petrolatum) in a Buehler test: 40% (4/10) of the test animals exhibited erythema, 30% also edema of the challenge test region. The sensitivity of the strain is considered positive.
Reading:
1st reading
Hours after challenge:
30
Group:
test chemical
Dose level:
50% w/w
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
54
Group:
test chemical
Dose level:
50% w/w
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
50% w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
50% w/w
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Group:
positive control
Dose level:
50% 2-mercaptobenzothiazole
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
4/10 exhibited erythema, 3/10 also edema
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is considered to be not sensitising. The study is considered to be relevant and reliable.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Only a single study conducted according to guideline OECD 406 and under GLP is available. The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. The Buehler sensitisation test showed that the test substance is not sensitizing (0/20 animals showed any reaction).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results indicate the substance is not a skin sensitizer. As a result the substance does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, Part 3, 3.4.2.2.