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EC number: 204-690-6 | CAS number: 124-22-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study similar to Guideline but only 4 animals (2 males/2females) per dose group used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 4 animals per dose group used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, coco alkyl
- EC Number:
- 262-977-1
- EC Name:
- Amines, coco alkyl
- Cas Number:
- 61788-46-3
- IUPAC Name:
- 61788-46-3
- Reference substance name:
- Coco Alkylamines
- IUPAC Name:
- Coco Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Amine KK
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Interfauna UK Limited, Huntingdon, Cambridgeshire, UK
- Age at study initiation: approx. 6 - 8 weeks
- Weight at study initiation: 200 - 245 g
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- The compound was administered either unchanged at a volume of 0.63 mL/kg (= 500 mg/kg) or in water at a volume of 5 mL/kg (=2000 mg/kg).
Since the compound is described as corrosive and dermal irritative reactions were noted in the 500 mg/kg group (undiluted test material), dilution
for testing of the acute dermal toxicity at 2000 mg/kg bw is justifiable.
TEST SITE
- Area of exposure: 10% of total body surface
- % coverage: 100
- Type of wrap if used: occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.63 ml/kg (undiluted, 500 mg/kg group); 5 ml/kg (40% solution, 2000 mg/kg group)
- Concentration (if solution): 40% in water (only for 2000 mg/kg dose group)
VEHICLE
- water (only for 2000 mg/kg dose group) - Duration of exposure:
- 24h
- Doses:
- 500 mg/kg bw (undiluted)
2000 mg/kg bw (diluted to 40% w/v in water) - No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: 500 mg/kg/bw: no clinical signs throughout observation period 2000 mg/kg/bw: hunched posture, abnormal gait (waddling), lethargy, and decreased respiratory rate (shortly after treatment, free of symptoms thereafter)
- Gross pathology:
- Terminal autopsy revealed slight bruising in the subcutaneous tissue of one male and one female rat dosed at 500 mg/kg bw and scab formation with or without ulceration was seen in all rats dosed at 2000 mg/kg bw.
An area of minimal congestion of the stomach (mucosal aspect) was seen in one female rat dosed at 2000 mg/kg bw. - Other findings:
- Dermal reactions:
necrosis in all rats dosed at 500 mg/kg bw, persisting until day 12
well defined to moderate oedema in rats dosed at both levels
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose (LD 50) of Amine KK to rats was greater than 2000 mg/kg body weight
- Executive summary:
In a GLP-compliant study similar to OECD TG 402, the test compound Amine KK (cocoalkylamine), a yellow liquid (purity 100%), was dermally applied under occlusion to Sprague-Dawley rats. At a dose level of 500 mg/kg body weight, the test material was applied undiluted (application volume 0.63 ml/kg bw), at a dose level of 2000 mg/kg bw the substance was diluted to a 40% solution (w/v) in distilled water (application volume 5 ml/kg). Compared to a regular OECD TG 402 study a reduced number of animals was used (4 instead of 5 animals/dose). There were no mortalities, hence, the LD50 is > 2000 mg/kg bw. No clinical signs were observed at 500 mg/kg bw. At 2000 mg/kg, hunched posture, abnormal gait, lethargy and decreased respiratory rate were noted. Signs of dermal reactions at the application site of both treatments were well defined to moderate oedema until days 4-5. Hard scabs, persisting to the end of the observation period, frequently prevented the assessment of oedema
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