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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Industrial Biotest Laboratory was found to use fraudulent practices in some of their studies and reports. Since these studies were performed before the implementation of Good Laboratory Practices, it is not possible to verify the scientific credibility of most of these studies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanoic acid
EC Number:
203-838-7
EC Name:
Heptanoic acid
Cas Number:
111-14-8
Molecular formula:
C7H14O2
IUPAC Name:
heptanoic acid
Details on test material:
substance: heptanoic acid (SN-1767)
physical state : a clear, colorless liquid.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:no data
- Age at study initiation:no data
- Weight at study initiation:no data
- Fasting period before study:no data
- Housing: individually in suspended, wire-bottomed cages
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30 percent of the total body surface area, The animals were then returned to their cages to await testing on the following day. The 24-hour waiting period allowed recovery of the stratum corneum from the disturbance which accompanied the close-clipping procedure and permitted healing of any microscopic abrasions possibly produced during the process.
The test material was applied at the highest reasonable dose level. The test site was covered by wrapping the trunk of the animal with impervious plastic sheeting which was securely taped in place. This plastic wrap insured close contact of the epidermis and test material. To prevent oral ingestion of the test material, each animal was fitted with a light-weight, flexible plastic collar which was worn throughout the observation period
Duration of exposure:
24 hours
Doses:
1 dose : 2000 mg/kg bw
No. of animals per sex per dose:
2 animals/sexe/dose
Control animals:
no
Details on study design:
The test material remained in contact with the skin for 24 hours. At the end of this period, the plastic sheeting and ail residual test material were removed. The test sites were examined for local skin reactions and the animals were returned to their cages. Observations for mortality, local skin reactions, and behavioral abnorrnalities were continued for a total of 14 days following the skin applications. Initial, 7 and 14-day body weights were recorded. A necropsy examination was conducted on all animals.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
1 male died after 14 days of observation.
Clinical signs:
The skin at the site of application was abraded in one male and in one female.
The test material was severely irritating to the skin of the albino rabbit. Skin changes at 24 hours were characterized by beet red erthema, severe edema and second and third degree burns. Necrosis was observed at the test skin sites at 7 and 14 days.
Body weight:
Adverse body weight effects were noted in all of the rabbits during the 14 day observation period.

Applicant's summary and conclusion

Conclusions:
Heptanoic acid is slightly toxic with a LD50 > 2000 mg/kg bw