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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between November 1998 and 27 December 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
other: Commission Directive 92/69/EEC, B6 (Magnusson and Kligman maximisation test).
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was carried out before a formal requirement for an LLNA test was in place.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
a)Intradermal Induction:
0.5% (w/v) in arachis oil BP
0.5% (w/v) in Freund's Complete Adjuvant plus distilled water in the ratio 1:1

b)Topical Induction: 50% (w/w) in arachis oil BP.
Concentration of test material and vehicle used for each challenge:
a) 2% (w/w) in arachis oil BP
b) 1% (w/w) in arachis oil BP
Adequacy of induction:
highest technically applicable concentration used
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a)Intradermal Induction: 0.5% (w/v) in arachis oil BP

0.5% (w/v) in Freund's Complete
Adjuvant plus distilled water in the ratio 1:1.

b)Topical Induction: 50% (w/w)* in arachis oil BP.


*maximum concentration practical for topical application.

Concentration of test material and vehicle used for each challenge:
a) 2% (w/w) in arachis oil BP

b) 1% (w/w) in arachis oil BP
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

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

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 2 %

Signs of irritation during induction:
Intradermal Induction:
Well-defined or moderate to severe erythema was noted at the
intradermal injection sites of all test group animals at the
24 and 48-hour observations. Very slight to well-defined
erythema was noted at the intradermal injection sites of all
control group animals during this period.

Topical Induction:
Very slight to well-defined erythema, with or without very
slight to slight oedema, was noted at the topical induction
sites of all test group animals at the 1-hour observation.
Very slight to well-defined erythema, with or without very
slight oedema, persisted at the topical induction sites of
all test group animals at the 24-hour observation. Bleeding
from the intradermal injection sites was noted in eight test
group animals with subsequent small superficial scattered or
dark brown/black coloured scabs in four test group animals
at the 24-hour observation.

Very slight erythema was noted at the topical induction
sites of two control group animals at the 1-hour
observation. Bleeding from the intradermal induction sites
was noted in four control group animals.

Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of senitisation at each
challenge concentration: 0/9.

2% w/w in Arachis oil BP:
No skin reactions were noted at the challenge sites of the
test or control group animals at the 24 or 48-hour
observations.

1% w/w in arachis oil BP:
No skin reactions were noted at the challenge sites of the
test or control group animals at the 24 or 48-hour
observations.

Other observations:
Bodyweight gains of animals in the test group, between day 0
and day 24, were comparable to those in the control group.

One test group animal was found dead on Day 22. This was not
considered to affect the purpose or integrity of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met