Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Eastman TEG-EH
- Description: Eastman(TM) TEG-EH (Triethylene Glycol Bis (2-EthylHexanoate)) Plasticizer
- Physical state: clear colourless liquid
- Specific gravity: 0,959 (provided in report); 0,968 (20/20C; provided in certificate of analysis)
- Analytical purity: 99,1% (ester by GC)
- Impurities (identity and concentrations): see confidential details on test material
- Composition of test material, percentage of components: see confidential details on test material
- Purity test date: 2007-07-11
- Lot/batch No.: TD-7022702
- Expiration date of the lot/batch: not provided (production date = 2007-07-11)
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: The bodyweight variation did not exceed ± 20% of the initial mean bodyweight of any previously dosed animal(s).
- Fasting period before study: yes
- Housing: The animals were housed in groups of up to four
- Diet (e.g. ad libitum): ad libitum (Certified Rat and Mouse Diet) with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Water (e.g. ad libitum): ad libitum with the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Relative humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

IN-LIFE DATES: From: 2007-08-23 To 2007-09-27

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.09 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
One female was exposed to 2000 mg/kg (chosen as the starting dose based on vailable information on the toxicity of the test material). No toxicity were observed.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Individual Clinical Observations and Mortality Data

Dose

Level

mg/kg

Animal

Number

and Sex

Effects Noted After Dosing

(Hours

Effects Noted During Period After Dosing

(Days)

'/2

1

2

4

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2000

1-0

Female

0

0

0

0

'0

0

0

0

0

0

0

0

0

0

0

0

0

0

2-0

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2-1

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2-2

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2-3

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD50 > 2000 mg/kg
Executive summary:

Following a sighting test in which there was no mortality at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of undiluted test material, at a dose level of 2000 mg/kg. Clinical signs and bodyweight development were monitored during the study. There were no deaths, nor any signs of systemic toxicity. All animals showed expected gains in bodyweight, and no abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).