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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:
4 March - 24 April 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
430-550-0
EC Name:
-
Cas Number:
1671-49-4
Molecular formula:
C8H9NO4S
IUPAC Name:
4-methanesulfonyl-1-methyl-2-nitrobenzene
Details on test material:
- Physical state: white solid
- Storage condition of test material: ambient temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 272-345 g
- Housing: 5 per cage in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet: FD1 ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-23°C
- Humidity: 30-70%
- Air changes: minimum of 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 9 March 1999 To: 24 April 1999 (positive control study 25 January 1999- 19 February 1999)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
3% w/v for intradermal induction, 75% w/v for topical induction, 50% w/v and 25% w/v for challenge applications
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
3% w/v for intradermal induction, 75% w/v for topical induction, 50% w/v and 25% w/v for challenge applications
No. of animals per dose:
20 test and 10 controls
Details on study design:
RANGE FINDING TESTS: Groups of 2 or 4 female guinea pigs used and up to 4 dose-levels tested per group to determine dose levels to use for each of the 3 stages of the main study. Intradermal injection: 0.3, 1, 3 and 10% tested. Topical induction: 97 and 75% tested. Challenge: 96, 75, 50 and 25% tested.

MAIN STUDY
A. INDUCTION EXPOSURE - intradermal injection
- Test groups: 3 pairs of injections (0.05-0.1 mL each) of (i) Freund's complete adjuvant (FCA) plus corn oil in ratio 1:1, (ii) 3% w/v preparation of test substance in corn oil, (iii) 3% w/v preparation of test substance in a 1:1 preparation of FCA plus corn oil
- Control group: as for test group except corn oil instead of test substance
- Site: scapular region, row of 3 injections on each side of mid-line
- Frequency of application: single

B. INDUCTION EXPOSURE - topical application (one week after injections)
- Test groups: 200-300 mg of a 75% w/v preparation in corn oil applied on filter paper (approximately 4 cm x 2 cm) under an occlusive dressing for at least 48 hours
- Control group: as for test group except corn oil only applied
- Site: scapular region
- Frequency of application: single

c. CHALLENGE EXPOSURE (two weeks after topical induction)
- Test and control groups: 0.05-0.1 mL of a 50% w/v and a 25 % w/v preparation of the test substance in corn oil were each applied to the shorn flank (50% on left, 25% on right) on a piece of filter paper (approximately 1 cm x 2 cm) under an occlusive dressing for at least 24 hours.
- Evaluation (hr after challenge): 1 and 2 days

OTHER:
Positive control substance(s):
yes
Remarks:
hexylcinnamaldehyde

Results and discussion

Positive control results:
Following challenge of previously induced guinea pigs with undiluted hexylcinnamaldehyde, the net percentage response was 100%. Hexylcinnamaldehyde was classified as an extreme sensitiser and, therefore, confirmed the validity of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 17.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
19
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 19.0. Total no. in groups: 19.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
19
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 19.0. Total no. in groups: 19.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: negative control (positive control study)
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: negative control (positive control study). Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: negative control (positive control study)
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: negative control (positive control study). Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Table 1: Maximisation test: Number of animals with signs of allergic skin reactions

Scored after:

24 hours

48 hours

Test groups

50% w/v preparation

17/20

5/20

 

25% w/v preparation

1/20

0/20

Negative/vehicle control

50% w/v preparation

4/10

3/10

 

25% w/v preparation

0/10

0/10

Positive control

19/19 (0/10 control)

19/19 (0/10 control)

 

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The substance is considered to be a moderate skin sensitiser.
Executive summary:

The sensitisation potential of the test substance was assessed using a method based on the maximisation test described by Magnusson and Kligman. The study involved two main procedures: the potential induction of an immune response and a challenge of that response. The sensitisation response was determined 1 and 2 days after challenge by assessing the degree of erythema.

Challenge of previously-induced guinea pigs with a 50% w/v preparation of the test substance in corn oil elicited a moderate sensitisation response and challenge at 25% elicited a weak skin sensitisation response.

A positive control study using hexylcinnamaldehyde demonstrated the sensitivity of the test system.

The substance is considered to be a moderate skin sensitiser.