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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:
2007-02-05 to 2007-03-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
Tall-oil pitch
EC Number:
232-414-4
EC Name:
Tall-oil pitch
Cas Number:
8016-81-7
Molecular formula:
UVCB substance molecular formula unknown
IUPAC Name:
8016-81-7
Details on test material:
- Name of test material (as cited in study report): Tall Oil Pitch PN

- Physical state: Viscous liquid

- Storage conditions: Room temperature < 25°C, in the dark, may be used under light

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld

- Age at study initiation: 5 - 7 weeks

- Weight at study initiation: 363 g to 429 g

- Housing: Group caging in plastic containers (46 cm x 105 cm x 36 cm), partly shaded, 10 animals per container.

- Diet: Ssniff Ms-H (Guinea Pig Maintenance Diet V2233), includes ascorbic acid (2400 mg/kg), ad libitum.

- Water: Tap water from Makrolon-bottles with stainless steel canules, ad libitum.

- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): Mean of 22.0°C (continuous control and recording)

- Humidity (%): Mean of 47.1 % (continuous control and recording)

- Air changes (per hr): Approximately 12/h

- Photoperiod (hrs dark / hrs light): 12/12



IN-LIFE DATES: From: 2007-02-21 To: 2007-03-29

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 75%

Challenge: 25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 75%

Challenge: 25%
No. of animals per dose:
Test group: 20

Control group: 10
Details on study design:
RANGE FINDING TESTS:

To obtain the appropriate concentrations of the test substance for the definitive study, a preliminary test was carried out with 3 female guinea pigs. 4 different concentrations of the test substance were administered epicutaneously. The modes of application were the same as in the definitive study. The duration of the epicutaneous exposure was 6 hours.See Table 1 for scores.


MAIN STUDY

A. INDUCTION EXPOSURE

- No. of exposures: 3

- Test groups: Test substance in corn oil

- Control group: Corn oil only

- Site: Left flank

- Frequency of applications: Days 0, 7 and 14

- Duration: 6 hours

- Concentrations: 75% w/v


B. CHALLENGE EXPOSURE

- No. of exposures: 1

- Test groups: Test substance in corn oil

- Control group: Corn oil only

- Day(s) of challenge: Day 28

- Exposure period: 6 hours

- Site: Right posterior flank (test susbtance); Right anterior flank (corn oil)

- Concentrations: 25% w/v

- Evaluation (hr after challenge): 24 and 48


Positive control substance(s):
yes
Remarks:
hexyl cinnamic aldehyde

Results and discussion

Positive control results:
The sensitivity and the reliability of the experimental procedure is checked separately, twice a year, using !-hexyl cinnamic aldehyde as sensitizer and the same strain of animals and the same experimental procedure as in the study.

5/10 animals had a positive response in this test, which is markedly more than the minimum of 15 %, the threshold for classification requested by the guideline.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Shortly after the beginning of all exposures (induction and challenge) animals exhibited increased motor activity that was attributed to restricted movement due to the dressings used.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Shortly after the beginning of all exposures (induction and challenge) animals exhibited increased motor activity that was attributed to restricted movement due to the dressings used. .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

No skin reactions were observed at any time in either test group or negative control animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a reliable study conducted according to OECD Test Guideline 406, Tall Oil Pitch was found to be not sensitising. The test was conducted in compliance with GLP.

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