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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pivaloyl chloride
EC Number:
221-921-6
EC Name:
Pivaloyl chloride
Cas Number:
3282-30-2
Molecular formula:
C5H9ClO
IUPAC Name:
2,2-dimethylpropanoyl chloride
Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 99% on the MSDS.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: The males and females weighed 225-269 g and 183-222 g when tested, respectively.
- Fasting period before study: 16 hours prior to treatment
- Diet: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
500, 650 or 800 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
Animals were observed at least 3 times on the day of treatment and at least once daily thereafter for 14 days.
Body weights were recorded just prior to treatment and on Days 7 and 14 (or early as possible after death). A gross necropsy was performed on each animal that died or upon euthanization on day 14.
Statistics:
The LD50 values were calculated by the method of Litchfield and Wilcoxon (J Pharm Ther 96: 99-115, 1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
638 mg/kg bw
95% CL:
557 - 737
Remarks on result:
other: The LD50 values in males and females (with 95% confidence limits) are 657 (537-805) mg/kg and 621 (491-784) mg/kg, respectively. The slopes of the curves for males, females and all animals were 1.33, 1.21 and 1.26, respectively.
Mortality:
The number of deaths (and time of death) in the 500, 650 and 800 mg/kg groups were as follows: 1 female (6 hours) and 1 male (Day 4); two males (within Day 3) and two females (Days 1 and 5); and 4 males (within Day 3) and all 5 females (within Day 2).
Clinical signs:
other: Toxicological effects observed during the study included activity decrease, ataxia, body tremors, bradypnea, chromodacryorrhea, constricted pupils, diarrhea, dilated pupils, emaciation, exophthalmos, gasping, hematuria, lacrimation, melanuria, nasal disch
Gross pathology:
Low-dose animals and the one high-dose animal that survived to study termination had no observable abnormalities upon necropsy. Mid-dose animals that survived to study termination exhibited a thickened stomach wall that adhered to surrounding organs. One mid-dose animal had yellow nodules throughout the thickened area.
Necropsy findings observed in animals that died included signs of diarrhea, emaciation, lacrimation, nasal discharge, polyuria, salivation, GI tract distended with gas, discoloration of the contents of the GI tract, empty GI tract, serosal blood vessels pronounced along the GI tract, discoloration of the stomach mucosa, nodules on stomach wall, stomach wall thickened, stomach wall ruptured, stomach adhered to other tissues, edematous lungs, discoloration of the lungs, discoloration of the liver and/or testes drawn into abdominal cavity.

Applicant's summary and conclusion

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