Registration Dossier
Registration Dossier
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EC number: 605-460-1 | CAS number: 167004-78-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phosphinic acid, P-[3-(acetyloxy)-3-cyanopropyl]-P-methyl-, butyl ester
- EC Number:
- 605-460-1
- Cas Number:
- 167004-78-6
- Molecular formula:
- C11 H20 N O4 P
- IUPAC Name:
- Phosphinic acid, P-[3-(acetyloxy)-3-cyanopropyl]-P-methyl-, butyl ester
- Details on test material:
- Molecular weight: 261 g/mol
Molecular formular: C11H2ONO4P
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Test substance Hoe 125869, Identification: C00083/001
- Purity, including information on contaminants, isomers, etc.: 88.4% (w/w)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: -20 °C, darkness
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Age at study initiation: approx. 3 - 5 months
- Weight at study initiation: 2.5-2.8 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): ssniff® K-H (V2333), ad libitum
- Water (e.g. ad libitum): tap water from automatic water dispensers, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs light): 12 hours per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 - 60 minutes, and 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to the score of DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test substance caused minor dermal reactions in the form of very slight erythema in two animals 30 - 60 minutes after removal of the plaster.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the evaluated conditions, the test substance shows no skin irritating potential.
- Executive summary:
0.5 mL of the test item was tested for primary dermal irritation in 3 female New Zealand White rabbits. The exposure period was 4 hours. After the exposure period, the remaining test substance was removed carefully with warm tap water.
Examinations of the skin took place after 30-60 minutes as well as 24, 48 and 72 hours after removal of the patches. Additionally the animals were observed for any clinical signs of systemic toxicity.
The test substance caused minor dermal reactions in form of very slight erythema in two animals 30-60 minutes after removal of the plaster.
Overall, mean scores for dermal irritation after 24, 48 and 72 hours were 0.0 for erythema and eschar formation and 0.0 for oedema formation. No clinical signs of systemic toxicty were observed.
Based on the results obtained, the test item does not show skin irritant potential.
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