Registration Dossier
Registration Dossier
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EC number: 220-482-8 | CAS number: 2781-11-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jul - 16 Dec 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Version / remarks:
- 1978
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
- EC Number:
- 220-482-8
- EC Name:
- Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
- Cas Number:
- 2781-11-5
- Molecular formula:
- C9H22NO5P
- IUPAC Name:
- diethyl {[bis(2-hydroxyethyl)amino]methyl}phosphonate
- Test material form:
- liquid: viscous
- Details on test material:
- - Physical state: viscous liquid
- Colour: amber
- Expiry date: not reported
Constituent 1
- Specific details on test material used for the study:
- - Receipt date: 25 Jun 1981
- Color: amber
- Form: viscous liquid
Test animals
- Species:
- rabbit
- Strain:
- other: Stauffland albino rabbits
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, USA
- Weight at study initiation: 1.550-1.866 kg
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: abdominal skin
- Treatment of skin: abration of skin on half of the test animals
- Type of wrap: protective binder (during treatment with test material), gauze binder (during 14-day follow-up period)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and females per dose and 2 males and females per control
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: minimally twice a day; only once a day on holidays and weekends
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: other: Mild depression in all rabbits; one rabbit with diarrhea.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
- Other findings:
- - Local dermal effects: mild erythema and edema
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study performed according to the OECD TG 402, groups of Stauffland albino rabbits (5/sex) were dermally exposed to the undiluted test material for 24 hours to abraded and unabraded abdominal skin at doses of 2000 mg/kg bw. Animals then were observed for 14 days.
No mortality occurred during the study period. The only adverse clinical sign in all rabbits was mild depression. One rabbit had diarrhea.
Necropsy and histopathological examination revealed no substance-related findings.
Local dermal effects included mild erythema and edema.
Combined Dermal LD50 > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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