Registration Dossier
Registration Dossier
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EC number: 605-830-2 | CAS number: 178671-69-7
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:
- other: Guideline study conducted in accordance with GLP
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Department of Toxicology of BASF Aktiengesellschaft
Test material
- Reference substance name:
- Pentaerythritoltetracyanoacetic ester
- EC Number:
- 605-830-2
- Cas Number:
- 178671-69-7
- Molecular formula:
- C17 H16 N4 O8
- IUPAC Name:
- Pentaerythritoltetracyanoacetic ester
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.93 - 3.97 kg
- Housing: Single housing in Stainless steel wire mesh cages with grating, floor area: 3000 cm squared
- Diet: Kliba-Labordiät, Klingentalmühle AG Kaiseraugst, Switzerland, (about 130 g per animal per day)
- Water: About 250 ml tap water per animal per day
- Acclimation period: at least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Concentration: 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol(R) and Lutrol(R)/water (1:1).
SCORING SYSTEM: according to OECD guideline no. 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: mean of 24 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no skin reactions noted
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: mean of 24 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no skin reactions noted
- Irritant / corrosive response data:
- All scores in all animals were zero at any point of time during the course of the study.
Any other information on results incl. tables
Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means.
| Readings | Animal | Erythema | Edema |
| 1h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 24 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 48 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 72 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| Mean | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| Mean | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the skin.
- Executive summary:
In an in vivo skin irritation study performed according to OECD guideline no. 404 and in compliance with GLP, the potential of the test substance to cause acute dermal. irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance
to the intact skin of 3 New Zealand White rabbits for 4 hours under semiocclusive dressing. As no skin findings were observed in all animals within 72 hours after removal of the patches, the study was terminated. Under the test conditions chosen and considering the described findings the test compound does not give indication of an irritant property to the skin.
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