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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Similar substance #2
IUPAC Name:
Similar substance #2

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's adjuvant, distilled water
Concentration / amount:
Intradermal induction: 5%
Epicutaneous induction: 50%
Epicutaneous challenge: 20%
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.