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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Reference Type:
other: monograph provided by ECHA
Title:
Endpoint record:Skin sensitisation
Author:
ECHA
Year:
2010
Bibliographic source:
Document from ECHA

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Maximisation test of Magnusson and Kligman
Principles of method if other than guideline:
There is no need to add in this field.
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
75 - 95% (typical 88%, verified by UV/visible spectrum, Infrared (IR) spectrum, Nuclear Magnetic Resonance (NMR), and Mass spectrum.)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Day 1 – intradermal induction
Hair was removed from the shoulder region of animals and a row of three injections was made on each side of the midline.
Injections were
1:1 (v/v) Freunds Complete Adjuvant (FCA):water
5% (w/v) test substance in arachis oil
5% (w/v) test substance in a 1:1 preparation of FCA plus distilled water

Day 8 – topical induction
A patch containing test substance (75% w/w in arachis oil) was applied to the same site and secured with tape for 48 hours.
Day 22
Doses of 50 and 75% w/w of test substance in arachis oil were applied to the prepared flank of animalsNYOUYU and secured under occlusive conditions.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Day 1 – intradermal induction
Hair was removed from the shoulder region of animals and a row of three injections was made on each side of the midline.
Injections were
1:1 (v/v) Freunds Complete Adjuvant (FCA):water
5% (w/v) test substance in arachis oil
5% (w/v) test substance in a 1:1 preparation of FCA plus distilled water

Day 8 – topical induction
A patch containing test substance (75% w/w in arachis oil) was applied to the same site and secured with tape for 48 hours.
Day 22
Doses of 50 and 75% w/w of test substance in arachis oil were applied to the prepared flank of animalsNYOUYU and secured under occlusive conditions.
No. of animals per dose:
Test group: 10;
Control group: 5
Details on study design:
no data
Challenge controls:
Control animals were treated in a similar manner to test animals excluding the test substance.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Vehicle:
other: not conducted
Concentration:
not conducted
No. of animals per dose:
not conducted
Details on study design:
no data
Positive control substance(s):
not specified
Statistics:
no data

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were noted at the challenge sites of test
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were noted at the challenge sites of test .
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: not conducted
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not conducted

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 75%.

Signs of irritation during induction: Very slight (3 animals) to moderate to severe erythema (7 animals) was noted after the intradermal induction at the 24 hour reading, and very slight to severe erythema after 48 hours.

After topical induction, very slight erythema was oberved in all test animals and very slight oedema was noted in 4 test group animals at 1 -hour reading. No dermal reactions were noted after 24hours.

One test group animal was killed due to weight loss and breathing difficulties on day 16. These effects were not considered to be treatment-related.

.

No adverse effects on bodyweight gain were noted.

The test chemical was non-sensitising to the skin of guinea pigs

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test chemical was non-sensitising to the skin of guinea pigs.
Executive summary:

According to OECD TG 406, Maximisation test of Magnusson and Kligman was accomplished and concluded that test material did not induce skin sensitisation in guinea pigs.