Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-06-16 to 2009-06-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate

EC Number:

283-829-2

EC Name:

Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate

Cas Number:

84731-70-4

Molecular formula:

C24H44O4

IUPAC Name:

1,4-bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate

Test material form:

liquid

Specific details on test material used for the study:

Batch No.: 20090226
Purity: 99.38%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Orient Bio Ltd, 143-1 Sangdaewon-dong, Jungwun-Gu, Seoungnam-Si, Gyeonggi-Do, South Korea
- Age at study initiation: 7-8 wks
- Weight at study initiation: 179.1 to 227.5 g
- Fasting period before study: Yes, overnight
- Housing: 3-4 animals per stainless steel wire cage (255 width x 465 mm length x 200 mm height)
- Diet: Ad libitum pellet chow
- Water: Ad libitum
- Acclimation period: 5-15 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19~25 °C
- Humidity: 30~70 %
- Air changes: 10~20 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg bw as recommended by OECD Guideline 423, with the next dose determined as per the flow chart in the guidance following a 2 d observation period after treatment.

Doses:

300 mg/kg bw, 2000 mg/kg bw

No. of animals per sex per dose:

6 females per dose (0 males)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations on days 0, 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross findings.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Liquid faeces in 1/6 rats at 300 mg/kg bw dose level 1 hr after dosing; soft faeces in 2/6 rats at 2000 mg/kg bw dose level 1 hr after dosing. These were considered to be due to chance, rather than be associated with the test item because they occurred a

Gross pathology:

No treatment-related effects.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The test substance was assessed for acute oral toxicity according to OECD Guideline 423. The LD50 of the test material, DEHCH was >2,000 mg/kg bw in female rats. The substance is therefore not classified.