Registration Dossier
Registration Dossier
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EC number: 261-684-6 | CAS number: 59272-84-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- occlusive dressing, males and females tested, no stepwise approach, limited information, dilution of substance
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
- EC Number:
- 261-684-6
- EC Name:
- (carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
- Cas Number:
- 59272-84-3
- Molecular formula:
- C21H42N2O3
- IUPAC Name:
- (carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Cpb:Wu
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males: 310 to 376 g; females: 170 to 210 g
- Fasting period before study: no
- Housing: groups of five, males and females separated, in stainless steel cages with grid-bottom and front
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and ventral side of the trunk and flanks
- % coverage: not specified
- Type of wrap if used: plastic film secured by an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and handsoap
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 mL/kg bw
- Concentration: 25%
- Constant concentration used: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Skin readings were made immediately after dressing removal, and after a period of three days. The rats were observed for signs of intoxication frequently during the application period and once daily throughout the observation period of 14 days. Body weights were recorded on Day 0, 7 and 14.
- Necropsy of survivors performed: yes
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 observed.
- Clinical signs:
- No signs of intoxication.
- Body weight:
- Individual body weights of the rats on Days 7 and 14 indicated growth retardation in the first post-treatment week and recovery to normal growth thereafter. The following body weights were measured for male rats: Day 0: 330 g, Day 7: 334 g, Day 14: 365 g and for female rats: Day 0: 204 g, Day 7: 206 g, Day 14: 217 g
- Gross pathology:
- No treatment-related gross alterations
- Other findings:
- - Skin observations: Skin readings after 24 hours and after 3 days were negative.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
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