Registration Dossier
Registration Dossier
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EC number: 232-414-4 | CAS number: 8016-81-7 The residue from the distillation of tall oil. It contains primarily high-boiling esters of fatty acids and rosin. It may also contain neutral materials, free fatty acids and rosin acids.
Skin sensitisation
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:
- 2 007
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
- 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
Constituent 1
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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