Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14/09/1984-19/10/1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: OS#63466G
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc, Boyertown (PA), USA
- Age at study initiation: not specified
- Weight at study initiation: 300-500 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes (duration not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-23-9°C (65-75°F)
- Humidity (%): 45-55
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14/09/1984 To: 19/10/1984

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 g
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 g
No. of animals per dose:
12
Details on study design:
RANGE FINDING TESTS: No
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: back
- Frequency of applications: 3 times weekly
- Duration: 3 weeks
- Concentrations: 0.5 g

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: all
- Control group:
- Site: back (different area to induction)
- Concentrations: 0.5 g
- Evaluation (hr after challenge): 6, 24 and 48 hours
Positive control substance(s):
yes
Remarks:
l-chloro-2,4-dinitrobenzene

Results and discussion

Positive control results:
The positive control material when tested as a 0.1% w/v suspension in 50% alcohol saline solutionwas considered to be a skin sensitizer in the albino guinea pig.

In vivo (non-LLNA)

Results
Reading:
other: all readings
Hours after challenge:
24
Group:
test group
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the test conditions, the test substance when dosed as supplied was not considered to be a primary skin irritant, in the albino guinea pig.