Registration Dossier
Registration Dossier
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EC number: 472-170-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/03/2006 - 29/08/2006
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Principles of method if other than guideline:
- The test material was applied to the epidermal surface of three skin discs for a contact period of 24 hours. At the end of the contact period the test material was removed using a jet of warm tap water. Corrosive substances produce an irreversible loss of normal stratum corneum integrity and function, this is measured as a reduction in the inherent TER. test materials that give a mean electrical resistance of 5 kOhm or less are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: B&K Universal Ltd Hull (UK)
- Age at study initiation: 21 - 23 d
- Acclimation period: 2 d
Test system
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 150µl - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 3 samples were used
- Number of animals:
- 1 animal (all samples were from the same animal)
- Details on study design:
- TEST SITE
- Area of exposure: 0.79 cm²
REMOVAL OF TEST SUBSTANCE
- Test material was scraped with a spatula
- Washing: with a jet of warm tap water
- Time after start of exposure: 24h
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Transcutaneous Electrical Resistance (TER)
- Value:
- ca. 3.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 24 hours. Max. score: 6.2. Reversibility: no data. (migrated information)
Any other information on results incl. tables
Test Material Contact Period |
Tissue Number |
TER (kOhm) |
Mean TER (kOhm) |
Standard Deviation |
24 Hours |
1 |
6.2 |
3.3 |
+/- 2.5 |
2 |
2.1 |
|||
3 |
1.7 |
Positive Control Contact Period |
Tissue Number |
TER (kOhm) |
Mean TER (kOhm) |
Standard Deviation |
24 Hours |
4 |
0.939 |
0.830 |
+/- 0.16 |
5 |
0.651 |
|||
6 |
0.900 |
Negative Control Contact Period |
Tissue Number |
TER (kOhm) |
Mean TER (kOhm) |
Standard Deviation |
24 Hours |
7 |
17.4 |
17.9 |
+/- 5.32 |
8 |
23.5 |
|||
9 |
12.9 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Potential to cause corrosion Criteria used for interpretation of results: EU
- Conclusions:
- The mean TER recorded for the 24 hour test material contact period was less than 5 kOhm.
Following assessment of the data the test material is considered to have the potential to cause corrosion in vivo.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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