Registration Dossier
Registration Dossier
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EC number: 213-156-1 | CAS number: 927-62-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.07.1985 - 12.08.1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- N,N-dimethylbutylamine
- EC Number:
- 213-156-1
- EC Name:
- N,N-dimethylbutylamine
- Cas Number:
- 927-62-8
- Molecular formula:
- C6H15N
- IUPAC Name:
- N,N-dimethylbutylamine
- Test material form:
- liquid: viscous
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
- Name of test material (as cited in study report): N,N-dimethyl-N-butylamine
- Substance type: aliphatic amine
- Physical state: liquid
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A. Tuck & Sons Ltd, Battlesbridge, Essex, UK
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: males 223-258 g; females 190- 207 g
- Housing: individually during the 24 h exposure period and then in groups of 5 by sex for the remainder of of the study
- Diet: standard laboratory rodent diet ad libitum
- Water: ad libitum
- Acclimation period: min 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/-2°C
- Humidity: 60-70%
- Air changes (per hr): 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: 6x12 cm
- % coverage: 10%
- Type of wrap if used: a patch of surgical gauze was held in palce with a strip of elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: yes; with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw; dose volume 2.78 mL/kg bw
- Constant volume or concentration used: na.a.; one dose only - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- observations: 0.5, 1, 2, 3, 4, and 5 hours following dosing, and then at least one per day
--weighing: on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight. - Statistics:
- not needed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: free base
- Mortality:
- No deaths occurred in the rangefinding or in the main study (i.e. 0 deaths in 14 exposed animals)
- Clinical signs:
- other: None of the rats showed clinical signs as repsonse to treatment.
- Gross pathology:
- No findings in final necropsies in any rat.
- Other findings:
- No local effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: other: lack of acute (systemic) toxicity; local skin effects (corrosion) was not reported but must be taken into consideration
- Conclusions:
- The dermal LD50 was >2000 mg/kg bw in the rat.
- Executive summary:
The acute dermal toxicity of N,N-dimethylbutylamine (2000 mg/kg bw; free base) was examined in a rat study (5 male and female Sprague Dawley rats) that was conducted according to OECD 402 and under GLP conditions. There were no deaths or clinical signs of toxicity including body weight in any of the rats within the 14-day observation period. Local skin effects were not reported but must be assumed because of the corrosivity of the free base. Thus the dermal LD50 in the rat was >2000 mg/kg bw in this study (Hewitt and Collier,1985).
This study is considered to be valid and suitable for assessment.
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