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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from secondary source

Data source

Reference
Reference Type:
other: Secondary source
Title:
Acute dermal toxicity of test chemical
Author:
U. S. Environmental Protection Agency (EPA)
Year:
2001
Bibliographic source:
U. S. Environmental Protection Agency (EPA), 2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To determine the acute dermal toxicity of test chemical in rabbits.
GLP compliance:
not specified
Test type:
other: Acute dermal toxicity
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, coco, N-(hydroxyethyl)
EC Number:
268-770-2
EC Name:
Amides, coco, N-(hydroxyethyl)
Cas Number:
68140-00-1
Molecular formula:
CH3(CH2)nCONHCH2CH2OH
IUPAC Name:
Amides, coco, N-(hydroxyethyl)
Details on test material:
IUPAC name: Amides, coco, N-(hydroxyethyl)

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 1.9 - 2.7 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Trunk
- % coverage: Not specified
- Type of wrap if used: plasticized material

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): Not specified
- Concentration (if solution): Not specified
- Constant volume or concentration used: yes/noNot specified
- For solids, paste formed: yes/noNot specified
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three male and three female rabbits
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not specified
- Necropsy of survivors performed: no
- Clinical signs including body weight : yes, observed
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: skin response and general behavior
Statistics:
Not specified

Results and discussion

Preliminary study:
Not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All animals survived.
Clinical signs:
All animals appeared normal through day 14.
Body weight:
Two females that had abraded skin lost weight (0.01 and 0.25 kg) over the 14-day post-exposure period. All remaining rabbits gained weight through day 14.
Gross pathology:
Not specified
Other findings:
Not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
Acute dermal toxicity study was performed on rabbits. The LD50 was determined to be > 2000 mg/kg bw indicating that the test chemical is not toxic in nature.
Executive summary:

An acute dermal toxicity study was performed on rabbits to determine the toxic nature of the test chemical. Three male and three female Albino Rabbits weighing 1.9 -2.7 kg were dosed at a single concentration of 2000 mg/kg bw. Prior to dosing the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application the trunk of each animal was encased in a sleeve of plasticized material for 24 hours. Following the 24-hour exposure period the sleeve was removed and the skin sites gently cleansed. All animals were observed daily thereafter for 14 days for mortality, skin response and general behavior. No mortality was observed, and all animals appeared normal during the 14 days observation period. Two females that had abraded skin lost weight (0.01 and 0.25 kg) over the 14-day post-exposure period. All remaining rabbits gained weight through day 14. Thus, the LD50 was observed to be >2000 mg/kg bw indicating that the test chemical is not toxic in nature and falls under category 'Not classified'.