Registration Dossier
Registration Dossier
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EC number: 266-942-1 | CAS number: 67701-23-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- Justification for read-across, see attached file.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tall oil
- EC Number:
- 232-304-6
- EC Name:
- Tall oil
- Cas Number:
- 8002-26-4
- Molecular formula:
- Not applicable - UVCB substance
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,5 ml of test substance
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Time point:
- other: 1h
- Score:
- 0
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mean Scores.:
Erythema / Eschar: 0,0 for all 3 animals
Oedema: 0,0 for all 3 animals - Executive summary:
Aim of the study
The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.
Methods
Methods and investigations were performed in accordance with the OECD Guideline 404 and the Directive 2004/73/EC, method B.4.
Administration of the test substance
0.5 mL "CRUDE TALL OIL" was applied via a patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours.
First the test substance was administered to one animal. As no serious skin reactions were noted in this animal, the remaining two animals were exposed to the test substance one week later.
Investigations
• Body weights: at the start and at the termination of the test.
• General signs of toxicity: once daily.
• Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).
Results
General signs of toxicity
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Skin examinations
• Erythema/Eschar: Not affected.
• Oedema: Not affected.
Residual test substance was noted on the exposed skin areas, resp. on the growing hair, until 72 h p.a.
Conclusion
The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:
Mean Scores.:
- Erythema / Eschar: 0,0 for all 3 animals
- Oedema: 0,0 for all 3 animals
According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for skin irritation
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