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Diss Factsheets

Administrative data

Description of key information

OECD406, GMPT, not skin sensitizer

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA method not available at the time of testing
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH & Co. KG, 4923 Extertal 1, FRG
- Weight at study initiation: 263 - 350 g
- Housing: in groups of 5 per Type IV Makrolon cage
- Diet (e.g. ad libitum): Kliba rabbit and guinea pig maintenance diet (341.4 mm); ad libitum
- Water (e.g. ad libitum): tap water (drinking water with about 2g of ascorbic acid in 10 I water twice a week); ad libitum
- Acclimation period: not less than 6 days before the start of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's adjuvant, distilled water
Concentration / amount:
Intradermal induction: 5%
Epicutaneous induction: 50%
Epicutaneous challenge: 20%
Route:
epicutaneous, occlusive
Vehicle:
other: Freund's adjuvant, distilled water
Concentration / amount:
Intradermal induction: 5%
Epicutaneous induction: 50%
Epicutaneous challenge: 20%
No. of animals per dose:
Test group: 20
Each control group: 10
Details on study design:
RANGE FINDING TESTS:
- Administration volume: Filter paper strips of 2 x 2 cm edge length were allowed to take effect in the region of the flank under occlusive conditions
- Exposure time: The test substance was administered for 2 x 24 hours within a period of 96 hours in order to detect unspecific phenomena which are not based on a sensitization reaction but which might displace the irritation threshold
- Site of administration: Region of the flank, in each case in the same place
- Number of animals: 4 for each test concentration
- Readings: Approximately 24 and 48 hours after the start of administration

MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL INDUCTION
- No. of exposures: 6 intradermal injections, two at a time, for each animal
- Exposure period: single application
- Two control groups: the animals received the same injections, but without the test substance and only with the agent which was used for preparing the suspension.
- Site: Shoulder region
- Concentrations: 5%

B. INDUCTION EXPOSURE: EPICUTANEOUS INDUCTION
- one week after intradermal induction
- Exposure: liquid immersed filter paper strips of 2x4 cm edge length under occlusive conditions
- No. of exposures: 1
- Exposure period: 48 h
- Site: shoulder region, in the same area as previously with the intradermal application
- Concentrations: 50%


C. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: the first dose approximately 14 days after the epicutaneous induction, the second dose one week later
- 1st challenge: test group and control group 1 (control group 2 untreated); 2nd challenge: test group and both control groups
- Exposure: liquid immersed filter paper strips of 2x2 cm length under occlusive conditions
- Exposure period: 24 h
- Site: intact clipped region of the flank
- Concentrations: 20%
- Evaluation (hr after challenge): approximately 24, 48, 72 hours after the start of administration
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no effects.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no effects.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
20%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no effects
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
24
Group:
other: negative control group 2
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: negative control group 2. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: negative control group 2
Dose level:
20%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: negative control group 2. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested

Remarks:1/10 animals of control group 1 died 4 days after intradermal induction

Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The substance was tested for skin sensitisation following OECD 406. The test substance did not show any sensitising potential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman according to OECD guideline 406 (BASF 1988). After the challenge application, no cutaneous reactions were observed in the animals of the control and test groups at the 24-hour and 48-hour readings.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

skin sensitizer Cat 1A, with GPMT:

≥ 30 % is responsive to ≤ 0,1 % of the intradermal induction dose or

> 60 % is responsive to > 0,1 %- ≤ 1 % of the intradermal induction dose

 

skin sensitizer Cat 1B, with GPMT

≥ 30 % to < 60 % is responsive to > 0,1 % - ≤ 1 % of the intradermal induction dose or,

≥ 30 % is responsive to > 1 % of the intradermal induction dose

 

Based on the results of the skin sensitization test (GPMT) the substance is not classified as skin sensitizer