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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 according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1996

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
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension

In vivo test system

Test animals

Strain:
other: Crl:(HA)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 3 weeks
- Housing: 4 cages, one cage per group of at most 10 animals
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 62.5-92.5%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.10.1995 To: 17.11.1995

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
maize oil
Concentration / amount:
1. induction: 3%
2. Induction: 50%
1. Challenge: 12.5 and 25%
2. Challenge: 12.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
1. induction: 3%
2. Induction: 50%
1. Challenge: 12.5 and 25%
2. Challenge: 12.5%
No. of animals per dose:
control: 3 males and 3 females
treated group: 5 males and 5 females
Details on study design:
RANGE FINDING TESTS:
intradermal injection with various concentrations in 3 animals for screening of mild irritating and well tolerated concentration
irritation response after tocical treatment was tested in 6 animals (naive) and 6 animals (FCA treated), reading for irritation response 24 h and 48 h after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Site: dorsal skin in the skapular region
- Exposure period: intradermal injection, topcial application 7 days later for 24 h


B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1 day application period, 1. Challenge 2 weeks after topical induction, rechallenge one week later; reading 24 and 48 h after pach removal
- Site: topcial application; 1. Challenge: 12.5% left flank, 25% right flank of animals; Rechallenge: left flank with 12.5% and diluent, avoiding overlapping with the site challenged one week before
- Concentrations: 12.5 and 25% (1. challenge), 0%, 12.5% rechallenge
- Evaluation (hr after challenge): 24 h
Positive control substance(s):
yes
Remarks:
benzocaine

Results and discussion

Positive control results:
A challenge treatment of 30% benzocaine in vaseline caused positive reations in 50% of the test animals, no reaction in the controls.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
12.5%
No. with + reactions:
3
Total no. in group:
6
Clinical observations:
very slight erythema (grade 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12.5%. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight erythema (grade 1).
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
12.5%
No. with + reactions:
3
Total no. in group:
6
Clinical observations:
very slight erythema (grade 1)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 12.5%. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight erythema (grade 1).
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:
1
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
6
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: 6.0. 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:
6
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: 6.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: maize oil alone
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: maize oil alone. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: maize oil alone
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: other: maize oil alone. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions tested, a challenge concentration of 12.5% of the test substance causes dermal effects in 60% of the animals, whereas a concentration of 25% showed 30% response only. This might be explained by a difference in skin penetration. A re-challenge resulted in a lesser response (less animals affected as well as weaker skin reactions). Therefore, the test substance is regarded as skin sensitizer.