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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: Study conducted according to protocol and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Existing study

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 6-11 weeks
- Weight at study initiation: 426-473 g
- Housing: Individually in wire mesh suspension cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours


IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction: 5%
Challenge: 1%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction: 5%
Challenge: 1%
No. of animals per dose:
38 (20 test, 10 naive control, 8 pilot)
Details on study design:
RANGE FINDING TESTS:
Primary Irritation after 6 hour patch aplication of test material in mineral oil at following concentrations:

Undiluted, 50, 25, 10, 5, 2.5, 1, 0.5 % w/v

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups:
- Control group:
- Site: Left shoulder
- Frequency of applications: 6 to 7 days
- Duration:
- Concentrations:


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 and 2 days (24 and 48 hours)
- Exposure period: 6 hours
- Test groups:
- Control group: 10 naive not previously exposed to test material
- Site:
- Concentrations:
- Evaluation (hr after challenge): 24 and 48 hours


OTHER:
Challenge controls:
10 naive not previously exposed to test material
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4,-Dinitrobenzene

Results and discussion

Positive control results:
Positive for skin sensitization

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
2
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 19.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
19
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: 19.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
CAS# 68784-31-6 is an analogue to the registered substance suitable for read-across. The test material did not cause sensitization in an OECD 406 study in guinea pigs induced at 5 wt% and challenged at 1 wt%. Similar mild to moderate irritation was observed during the challenge phase in induced and naive animals. Under the conditions tested, CAS # 68784-31-6 is not considered to cause skin sensitization.
Executive summary:

An OECD 406 Skin Sensitization study in Guinea Pig preceded by a Pilot Phase to select a proper concentration of the test material was performed to evaluate the sensitization potential of CAS# 68784-31-6. The pilot phase animals were subjected to a range of dilutions of substance to identify sufficiently low concentrations to avoid confounding irritation. Testing was conducted under semi-occluded patch conditions. Test solutions of 5 wt% for induction and 1 wt% for challenge were selected for the main study. 20 animals were induced and challenged in the main study. The testing was conducted under occluded patch conditions. Only mild to moderate responses were noted during the main phase of the study and were equivalent between challenge and naive control groups. It was concluded that the test material is non-sensitizing under the condition of this test.