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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Old study, not to GLP, but similar to current guidelines

Data source

Reference
Reference Type:
publication
Title:
The Toxicity of Allylamines
Author:
Hine, CH, et al
Year:
1960
Bibliographic source:
Archives of Environmental Health, Volume 1, Pages 343-352

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 3 animals per dose
GLP compliance:
no
Remarks:
Old study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Molecular weight: 57.09
Boiling point: 52.9 deg C
Melting point: -88.2 deg C
Flash point, tag open cup: -20 deg F
Specific Gravity, 20/4 C: 0.7627
Solubility in water, 20 deg C, %W: complete
pH of 0.1M aqueous solution: 11.2
ppm in 1 mg/mL: 429

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Animals weighed 2.0-2.8 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back/flanks
- % coverage: Not stated
- Type of wrap if used: rubber
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped dry
- Time after start of exposure: several hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): neat material, as required
- Concentration (if solution): N/A

Duration of exposure:
Several hours
Doses:
13, 25, 50 and 100 mg/kg
No. of animals per sex per dose:
3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes, where possible
Statistics:
LD50 calculated by method of Weil, 1952.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
35 mg/kg bw
Based on:
test mat.
Mortality:
13 mg/kg: 0/3
25 mg/kg: 0/3
50 mg/kg: 3/3 (4-24 hours)
100 mg/kg: (3-4 hours)
Clinical signs:
Considerable local erythema and oedema, progressing to eschar formation

Deaths occurred with no preliminary sign but head drop
Gross pathology:
Premature decedents usually had fluid in the pleural cavity and dilation of the gastroenteric veins. Microscopically all had severely congested lungs.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was 35 mg/kg
Executive summary:

Mortality in male rabbits was:

13 mg/kg: 0/3

25 mg/kg: 0/3

50 mg/kg: 3/3 (4-24 hours)

100 mg/kg: (3-4 hours)