Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-542-8 | CAS number: 108-01-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1991 - Jan 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according OECD 402 guideline. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA FR, Vol.50 188, September 27, 1985
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-dimethylaminoethanol
- EC Number:
- 203-542-8
- EC Name:
- 2-dimethylaminoethanol
- Cas Number:
- 108-01-0
- Molecular formula:
- C4H11NO
- IUPAC Name:
- 2-(dimethylamino)ethanol
- Details on test material:
- - Name of test material (as cited in study report): 6398-36-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: 91-018
- Stability under test conditions: no apparent change in the physical characteristics of the test article during administration.
- Storage condition of test material: no data
- Other:specific gravity= 0.886 g/ml
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Lab Products, Wayne, New Jersey
- Weight at study initiation: 8-12 weeks
- Weight at study initiation: 1.930-2.315 kg
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council
- Diet (e.g. ad libitum): Purina Rabbit Chow H.F., ad libitum,
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h dark/12h light
IN-LIFE DATES: From: 1991-11-01 To: 1991-11-15
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of trunk (clipped free of fur)
- % coverage: no data
- Type of wrap if used: rubber dam and an elastic bandage to retard evaporation
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with water and gauze
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg
- Constant volume or concentration used: yes
VEHICLE not applicable - Duration of exposure:
- 24 hours
- Doses:
- 3000 mg/kg
- No. of animals per sex per dose:
- 10 (5 ♂ and 5 ♀)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: daily through 14 days, body weight: d0, d7 and d14
- Necropsy of survivors performed: yes - Statistics:
- Statistics were calculated using Systat by Systat, Inc. Version 4.1, Evanston, IL.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 3 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- - 0/10 animals died at the 3000 mg/kg dose level
- Clinical signs:
- other: - decreased activity, abnormal stance and abnormal gait - necrosis of the skin at the application sites
- Gross pathology:
- - severe irritation of underlying muscle at the application sites was observed in all animals at terminal necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the Acute Exposure Dermal Toxicity Study in rabbits, the estimated acute dermal LD50 for 6398-36-1, Order #91-018, in males and females was determined to be greater than 3000 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
