Registration Dossier
Registration Dossier
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EC number: 944-290-5 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-08-18 to 2014-09-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay-Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg/Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- EC Number:
- 944-290-5
- Molecular formula:
- C38H80NO4PS2 (idealized)
- IUPAC Name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- Test material form:
- liquid: viscous
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: male: approx. 8 weeks, female: approx. 12 weeks
- Mean weight at study initiation: male: 231.6 g; female: 207.0 g
- Housing: Single housing in Makrolon cage, type III; Bedding H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
- Diet : ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 (Central air-conditioning)
- Humidity (%): 30 – 70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin (dorsal and dorso-lateral parts of the trunk)
- % coverage: at least 10
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
- removal with warm water
TEST MATERIAL
- Amount applied: 2.14 mL/kg bw
- Constant volume or concentration used: yes
The test substance was administered undiluted. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, weekly, last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology, skin observation
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- No signs of systemic toxicity were observed
The following test item-related local effects were recorded during the course of the study, local effects occurred within the first 10 days after administration:
- Very slight to moderate erythema (grade 1 to 3)
- Very slight to moderate edema (grade 1 to 3)
- Incrustations
- Scaling - Body weight:
- The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased within the normal range throughout the study period with one exception. One animal lost weight during the first week, probably due to the bandage procedure, but body weights were within the normal range during the second week.
- Gross pathology:
- No macroscopic pathologic abnormalities were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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