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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
Study period:
Single dose followed by a 14-day observation period
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliable without restriction; study was conducted according to OPPTS 870.1100 and OECD 425 guidelines and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
-Test substance (name as cited in study report): Eastman TXIB
-Source of test material: Eastman Chemical Company
-Purity: >98%
-Production date: 4/26/07
-Date of receipt: 7/26/07
-Stability: 1 year
-Storage: Room temperature and humidity
-Description: Clear liquid
-Specific gravity: 0.92

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Test animals:
-Strain: Wistar albino rats (Ace Animals, Boyertown, PA)
-Date of receipt: 7/24/07 and 7/31/07
-Sex: Female (non-pregnant and nulliparous)
-Number: 5
-Body weight: 201-237 g
-Age: Approximately 7-8 weeks of age
-Quarantine: at least 5 days
-Identification: tail tatoo

Environmental Conditions:
-Housing: 1 rat per suspended wire cage (bedding placed beneath the cage changed at least 3 times weekly)
-Feed: Fresh PMI Rat Chow (Diet 5012); ad libitum except for 16-20 hours prior to dosing
-Water: available ad libitum
-Light cycle: 12:12 light:dark

In Life Dates:
-Study initiation: 8/08/07
-Study termination: 8/30/07

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
One female rat was dosed with the undiluted test substance at 2000 mg/kg bw. Since the animal survived, four additional animals were administered the test substance at 2000 mg/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 female rats
Control animals:
no
Details on study design:
The test substance was used as received and the dose was based on the sample weight as calculated from the specific gravity. One animal was initially dosed with the test substance at 2000 mg/kg bw. Since the animal survived, another 4 animals were dosed at 2000 mg/kg bw followed by a 14-day observation period. Animals were observed at 0.5, 1, 2 and 4 hours post-dose and once daily thereafter. Body weights were recorded immediately prior to test substance administration, weekly, and at study termination. Gross pathology was performed on all animals.
Statistics:
Statistical analyses were not performed.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived the 14-day observation period.
Clinical signs:
Instances of wet anogenital area were observed on Days 0 and 1. All animals appeared normal from Day 2 through study termination.
Body weight:
All animals gained weight during the 14-day observation period.
Gross pathology:
No findings were noted; all animals were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under conditions used in this study, 2,2,4-trimethyl-1,3-pentanediol diisobutyrate was not toxic by the oral route in rats. The single dose oral LD50 in female rats was calculated to be > 2000 mg/kg bw.

Based on an acute oral LD50 value of > 2000 mg/kg bw in rats and an absence of significant toxic effects in humans or animals exposed to this chemical, 2,2,4-trimethyl-1,3-pentanediol diisobutyrate is not classified for acute lethality by the oral route under GHS. Based on an absence of significant target organ or other systemic effects, the test material is also not classified for Specific Target Organ Toxicity – Single Exposure under GHS.
Executive summary:

In an acute up and down oral toxicity study, five female rats were administered a single dose of 2,2,4-trimethyl-1,3-pentanediol diisobutyrate by oral gavage at 2000 mg/kg bw. The rats were observed for mortality and adverse clinical signs for a period of 14 days. All animals survived the observation period. Clinical observations were limited to wet anogenital area on study Days 0 and 1 in two animals. All animals appeared normal from study Day 2 to study termination and all animals gained weight during the observation period. Based on the present study, the oral LD50 in female rats administered 2,2,4-trimethyl-1,3-pentanediol diisobutyrate is > 2000 mg/kg bw and the test material is considered to present a low toxicity hazard by the oral route.