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Registration Dossier
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EC number: 951-477-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jul. 15, 2019 to Aug. 13, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2013, the 2nd edition
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium Nickel Manganese Magnesium Titanium Dioxide (Crystal phase: O3/P2/RS)
- EC Number:
- 951-477-5
- Molecular formula:
- Na1-δNivMnwMgxTiyO2, where the ranges are 0 < δ < 0.2, 0.2 < v < 0.4, 0.4 < w < 0.6, 0.02 < x < 0.2, 0.02 < y < 0.2
- IUPAC Name:
- Sodium Nickel Manganese Magnesium Titanium Dioxide (Crystal phase: O3/P2/RS)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Corn oil
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 3 min, 1 hour and 4 hours
- Observation period:
- 1 h, 24 h, 48 h and 72 h, 4 d-14 d after patch removal
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Could not be score because of breaking and bleeding of treated skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Could not be score because of breaking and bleeding of treated skin
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- For two animals (4 hours), treated skin were breaking and bleeding during the 14 days observation period. According to the CLP criteria for skin irritation/ corrosivity, the sample was Category 1B: Corrosive.
- Executive summary:
Introduction
Refer to the Ministry of Environmental Protection of the People's Republic of China “The Guidelines for Testing of Chemicals” (HJ/T 153-2004)-404. The study was performed to assess the acute dermal irritation/corrosion of TBM-141 in Japanese White rabbits.
Method
Three male rabbits were used for the study. 0.5 g of test chemical was applied to right side of back skin of one animal for an exposure period of 4 h, the untreated skin on the left back area of the animal served as control, serious reaction was observed. 0.5 g of test chemical was applied to right side of back skin of another animal for an exposure period of 3 min, the untreated skin on the left back area of the animal served as control, serious reaction was not observed. 0.5 g of test chemical was applied to other skin on the right back of this animal for an exposure period of 1 hour, the untreated skin on the left back area of the animal served as control, serious reaction of this animal was not observed. 0.5 g of test chemical was applied to other skin on the right back of this animal for an exposure period of 4 hours, the untreated skin on the left back area of the animal served as control. Observations of treated skin response were conducted immediately and at 1 h, 24 h, 48 h, 72 h, 4 d-14 d after patch removal. Dermal reactions are scored at 1h, 24h, 48h, 72h, 4 d-14 d after patch removal. Animals were weighted before dosing and at the end of the observation.
Results
No.1100 animal showed breaking and bleeding of treated skin after removal of the application immediately, last until 14 d after removal of the application.
No. 1101 animal the first application was removed after 3 min, no abnormality was found after removal of the application immediately, showed erythema 1 h after removal of the application, last until 4 days after removal of the application, no abnormality was found 5 days after removal of the application, last until 14 days after removal of the application. The second application was removed after 1 hour, no abnormality was found after removal of the application immediately, showed erythema 1 h after removal of the application, last until 13 days after removal of the application, no abnormality was found 14 days after removal of the application. The third application was removed after 4 hours, showed breaking and bleeding of treated skin after removal of the application immediately, last until 14 d after removal of the application.
For animals 1100，the skin erythema/ edema injury average score of the animal after removal of the application for 24 h, 48 h, 72 h was effected by breaking and bleeding of treated skin.
For animals 1101，application was removed after 3 min, the skin erythema/ edema injury average scores of the animals after removal of the application for 24 h, 48 h, 72 h were respectively 1.3/0. Application was removed after 1 hour, the skin erythema/ edema injury average scores of the animals after removal of the application for 24 h, 48 h, 72 h were respectively 3/0. Application was removed after 4 hours, the skin erythema/ edema injury average score of the animal after removal of the application for 24 h, 48 h, 72 h was effect by breaking and bleeding of treated skin.
All animals showed expected gain in body weight during the course of study.
Conclusion
For animals 1100 and 1101(4 hours), treated skin were breaking and bleeding during the 14 days observation period. According to the GHS criteria for skin irritation/ corrosivity, the sample was Category1: Corrosive.
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