Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles: pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Each animal received 10 applications with a two day rest period between the fifth and sixth application. Applications were once each day.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
10 exposures, 24 hours each time.
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
30 or 300 mg/kg
Basis:
analytical per unit body weight
No. of animals per sex per dose:
4
Control animals:
no

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Generally, animals which received the low dose showed an overall body weight gain; at the higher dose an overall slight weight loss was noted. Gross pathological findings at necropsy consisted of parasitic cysts in the liver and fibrous, pitted kidneys, congestion of the lungs, and congestion of the pancreas. For dermal observations, the low dose animals showed slight or moderate erythema, atonia, and desquamation. The exposed skin of one animal showed slight edema following the third and fourth application and a circumscribed area of corrosion during the last four days of the study. The high dose animals generally showed moderate erythema following all applications, slight to marked edema following the first five applications, and moderate or marked atonia and desquamation following the last seven applications. In three of the animals discolored areas which subsequently became necrosed were noted following the third application. The necrosis persisted throughout the study.

Applicant's summary and conclusion

Executive summary:

In this study, animals were repeatedly exposed to neopentanoic acid at concentrations of 30 or 300 mg/kg. Each animal was exposed dermally 10 times (once daily). Generally, animals which received the low dose showed an overall body weight gain; at the higher dose an overall slight weight loss was noted.  Gross pathological findings at necropsy consisted of parasitic cysts in the liver and fibrous, pitted kidneys, congestion of the lungs, and congestion of the pancreas.  For dermal observations, the low dose animals showed slight or moderate erythema, atonia, and desquamation.  The exposed skin of one animal showed slight edema following the third and fourth application and a circumscribed area of corrosion during the last four days of the study.  The high dose animals generally showed moderate erythema following all applications, slight to marked edema following the first five applications, and moderate or marked atonia and desquamation following the last seven applications.  In three of the animals discolored areas which subsequently became necrosed were noted following the third application.  The necrosis persisted throughout the study.