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Toxicological information

Acute Toxicity: dermal

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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:
1992
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

Constituent 1
Chemical structure
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

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:
- decreased activity, abnormal stance and abnormal gait
- necrosis of the skin at the application sites
Body weight:
d0-d7: ♀ decrease and ♂ increase
d7-d14 both ♂ and ♀: body weight increase
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.

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