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Diss Factsheets

Administrative data

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:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Remarks:
BASF AG, Experimental Toxicology and Ecology
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 520 F-Chlormethyloximether (Stufe 9 der BAS 520 FSynthese)
- Physical state: solid, crystalline / grey
- Analytical purity: 98.3 g/100 g
- Lot/batch No.: 29388-136
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc: DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 347-400 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): Kliba Labordiet
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days before the beginning of the study in the laboratory for dermal toxicity


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
Induction (intradermal injection): 2 injections each of 0.1 ml of a test substance formulation (5 % in olive oil),
Induction (epicutaneous): 1 ml of the test substance formulation (50 % in olive oil),
Challenge: 0.5 ml of the test substance formulation (25 % in olive oil)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
Induction (intradermal injection): 2 injections each of 0.1 ml of a test substance formulation (5 % in olive oil),
Induction (epicutaneous): 1 ml of the test substance formulation (50 % in olive oil),
Challenge: 0.5 ml of the test substance formulation (25 % in olive oil)
No. of animals per dose:
Number of animals in test group: 10
Number of animals in control group: 5
Details on study design:
RANGE FINDING TESTS: Dose rate for the main test were determined in the pretests. In the intradermal pretest, 6 intradermal injections were given in the shoulder of 2 per animals as follows:
- front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1: 1,
- middle row: 2 injections each of 0.1 ml of a test substance formulation in olive oil at 5% concentration,
- back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCI-solution (1: 1) with test substance at the 5 % concentration.
Readings were observed after 24 h. In front and back row, intense erythema and swelling were observed. In the middle row, moderate swelling was observed.
In the Epicutaneous Pretest, animals pretreated with Freund's adjuvant / 0.9% aqueous NaCI-solution (1 :1) each, in the same manner as intradermal pretest referring front row and back row without test substance 4 weeks prior to the application of the test substance were used. 2 x 2 cm gauze patches containing 0.5 ml of the test substance formulations at concentrations of 5, 10, 25 and 50% were applied to the skin of the flanks for 2 x 24 hours under an occlusive dressing. Readings were taken 24 h and 48 h after the beginning of application. 24 h after 1st epicutaneous application, discrete or patchy erythema were observed in both animals at concentrations 5-25 % and in one animals at 50% concentration. In the other animal at 50% concentration, moderate and confluent erythema was observed. 48 h after 1st application, both animals with concentrations 5-25 % recovered. No recovery was observed at 50% concentration. 24 h after 2nd application, similar results were observed as after 1st application at concentrations 5-25 %. At 50% concentration, both animals showed moderate and confluent erythema with were reduced to discrete or patchy erythema after 48 h.

MAIN STUDY
A. INDUCTION EXPOSURE- Intradermal
- No. of exposures: 6
- Test groups: as follows:
1) 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1: 1,
2) 2 injections each of 0.1 ml of a test substance formulation in olive oil at 5% concentration,
3) 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCI-solution (1: 1) with test substance at 5% concentration.
- Control group: same as in test group but the test substance was omitted.
- Site: shoulder
- Concentrations: 5%

INDUCTION EXPOSURE- Epicutaneous, 1 week after intradermal induction
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: under occlusive condition
- Control group: same as in test group but the test substance was omitted.
- Site: shoulder
- Frequency of applications: 1
- Duration: 48 h
- Concentrations: 50 %

B. CHALLENGE EXPOSURE
- No. of exposures: 2 (second challenge 7 days after 1st challenge)
- Day(s) of challenge: first challenge was performed 14 days after the epicutaneous induction. A second challenge was carried out one week after the first one
- Exposure period: 24 h
- Test groups: Epicutaneous under occlusive condition
- Control group: same as in test group but the test substance was omitted.
- Site: right flank anterior for test substance and left flank anterior for the vehicle
- Evaluation (hr after challenge): 24 and 48 h afterthe removal of the patch
Challenge controls:
yes, vehicle control group (n=5)
Positive control substance(s):
yes
Remarks:
see free text

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
2
Total no. in group:
5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 2.0. Total no. in groups: 5.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Signs of irritation during induction:
The intradermal induction caused moderate and confluent erythema in all test and control animals. The epicutaneous induction led to incrustation, partially open (caused by the intradermal induction), moderate and confluent erythema in addition to swelling in all test group and control animals.


Evidence of sensitisation of each challenge concentration:
After the challenges with a 25% test substance preparation in olive oil discrete or patchy erythema to moderate and confluent erythema, swelling and scaling could be observed in some test group animals. While the skin reactions observed in two test group animals after the  first challenge were reproducible by the 2nd challenge, the third animal with reactions after first challenge did not show any skin effects  after 2nd challenge. However, another animal was observed with skin effects after the 2nd challenge in the test group.

In addition the skin reactions observed in 2 animals of control group after the 2nd challenge application i.e. one week after the first skin contact to the test substance indicate the possibility of skin sensitization. Discrete or patchy erythema to moderate and confluent erythema  was noticed in control group animals (after the 2nd challenge).

Based on the results of this study, the test substance has a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen and can be classified as skin sensitizer.


Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information