Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Cas Number:
- 139734-65-9
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Test material form:
- other: 20% of the pure active substance in water
- Details on test material:
- - Name of test material: DOPA-Glycinate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Ico rat / OFA.SD (IOPS Caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo, Les Oncins, 69210 L’Arbresle, France
- Age at study initiation: 5–7 weeks
- Weight at study initiation: 203–277 g
- Housing: individually
- Diet: pelleted complete maintenance diet, ad libitum
- Water: filtered drinking water, ad libitum
- Acclimation period: 10 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: approx. 10% of the total body surface.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.98 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw (20% aqueous solution, "product by process")
- No. of animals per sex per dose:
- Preliminary study: Two groups with 2 males and 2 females
Main study: 5 males and 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs: Observations were made within 15 minutes after administration, then 1, 2 and 4 hours later and daily for the 14 day study period.
body weight: the body weight of each animal was recorded immediately before dosing on day 1, and on day 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 400 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- as manufactured (20% aqueous solution)
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: See 'Remarks'
- Body weight:
- other body weight observations
- Remarks:
- The body weight changes of the treated animals were rather identical to that of non-treated rats, housed under the same conditions.
- Gross pathology:
- No abnormality was noted upon necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The dermal LD50 (rat, male/female) of registration substance was >2000 mg/kg bw (as test material), corresponding to > 400 mg/kg bw as active ingredient.
- Executive summary:
The acute dermal toxicity of the registration substance was tested in Sprague-Dawley rats according to OECD guideline 402 (1987). A dose of 2000 mg/kg bw test item was applied once by the cutaneous route. No deviations from the methods prescribed by the guideline were reported.
Administration of the test material caused no mortality among the test animals.
Therefore, the LD50 was established above the limit dose of 2000 mg/kg bw in terms of test item as manufactured, corresponding to 400 mg a.i./kg bw.
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