Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
(Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl: HA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River, 97633 Sulzfeld, Germany- Age at study initiation: Approximately 6 weeks old- Weight at study initiation: 396 - 492 g- Housing: In groups- Diet ad libitum: Altromin 3122 maintenance diet for guinea pigs- Water ad libitum: tap water- Acclimation period: at least five days ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 3- Humidity (%): 55 +/- 10- Air changes (per hr): 10- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
intradermal induction: 2.5%epicutaneous induction: 1.5%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
epicutaneous challenge: 0.5%
No. of animals per dose:
test group 10 animals; negative and positive control group 5 animals each
Details on study design:
RANGE FINDING TESTS:A range finding test was performed with 10 animals. The concentrations used in the main experiment based on the results of this test.MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 2 (intradermal and epicutaneous, respectively)- Exposure period: single injection (intradermal) and 48 h (epicutaneous)- Test groups:Intradermal (3 pairs of injections): Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl Injection 2: a 2.5% concentration of the test item in physiological saline 0.9% NaClInjection 3: a 2.5% concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaClEpicutaneous: 1.5% in vaseline- Negative control group:Intradermal (3 pairs of injections): Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaClInjection 2: 100% physiological saline 0.9% NaClInjection 3: a 50% (v/v) formulation of physiological saline 0.9% NaCl in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaClEpicutaneous: pure vaseline- Positive control group:Intradermal (3 pairs of injections): Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaClInjection 2: 2% mercaptobenzothiazole in cottonseed oilInjection 3: a 50% (v/v) formulation of 2% mercaptobenzothiazole in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaClEpicutaneous: 25% mercaptobenzothiazole- Site: shoulder (intradermal + epicutaneous) - Frequency of applications: Intradermal Day 0, epicutaneous Day 7B. CHALLENGE EXPOSURE- No. of exposures: 1- Day of challenge: day 20- Exposure period: 24 hours- Test groups: 0.5% of test item in vaseline- Negative control group: vaseline- Positive control group: 15% mercaptobenzothiazole- Site: flank- Evaluation (hr after challenge): 24 and 48 h after removal of challenge patch.
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole

Results and discussion

Positive control results:
The positive control substance induced positive reactions in 5/5 animals (100%).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2%
No. with + reactions:
5
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
2%
No. with + reactions:
5
Total no. in group:
5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified