Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: US regulation, 21 CFR 191.10, application
Principles of method if other than guideline:
Method
A) on the intact skin of abdomen of guinea pigs
B) on the abraded skin of the back of guinea pigs
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butylamine
EC Number:
203-699-2
EC Name:
Butylamine
Cas Number:
109-73-9
Molecular formula:
C4H11N
IUPAC Name:
butan-1-amine
Test material form:
liquid
Details on test material:
n-Butylamine [CAS No. 109-73-9], from Eastman Organic Chemicals, not further specified

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Skin: shaved and depiliated
- Treatment sites:
A) on the intact skin of abdomen of guinea pigs
B) on the abraded skin of the back of guinea pigs
- Area of exposure: 1 square inch of cellulose pad


Duration of exposure:
24 h
Doses:
3 dose groups, no details
No. of animals per sex per dose:
4
Control animals:
not required

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
429 other: mg/kg bw (abdomen, intact skin)
Remarks on result:
other: 0.58 mL/kg bw given in publication
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 100 other: mg/kg bw (back, abraded skin)
Remarks on result:
other: 1.5 mL/kg bw given in publication
Mortality:
Numbers of deaths not reported.
A higher toxicity was observed for butylamine applied to the abdomen. 
Gross pathology:
Quick and severe skin necrosis
Other findings:
A higher toxicity was observed for butylamine applied to the abdomen, which may be explained by the higher sensitivity and responsiveness of the abdominal skin as compared with the dorsal skin.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Under the conditions of the test a dermal LD50 of 429 mg/kg bw was determined in male guinea pigs.
Executive summary:

The test substances were occlusively applied to the intact abdome skin or abraded back skin of guinea pigs under the conditions laid down in the US regulation, 21 CFR 191.10.

Quick and severe skin necrosis was observed at the application sites.

The LD50 was 0.58 mL/kg bw (429.0 other: mg/kg bw) for exposure to intact abdomen skin and 1.5 mL/kg bw (1100.0 mg/kg bw) for exposure to abraded back skin

The study examined a comparison between guinea pigs and rabbits in their response to various compounds in regard to acute dermal toxicity and primary irritation.

Of the eight compounds tested for acute dermal toxicity, only one (parathion) would have been placed in a higher toxicity classification by the rabbit test than by the intact guinea pig skin test.

The information obtained in the primary irritation tests showed that the intact guinea pig skin test is as sensitive as, or more sensitive than, the rabbit skin test in eliciting dermal reactions.