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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-28 to 2010-05-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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.: 20091203
Purity: 99.42%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories Ltd, Oxfordshire, United Kingdom
- Age at study initiation: 8-12 wks
- Weight at study initiation: ≥ 200 g
- Fasting period before study:
- Housing: Individually during 24 hr exposure period; in groups of 4 for remainder of study
- Diet: Ad libitum, 2014 Teklad Global Rodent diet.
- Water: Ad libitum, mains water
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19 °C to 25 °C
- Humidity: 30 % to 70 %
- Air changes: ≥ 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: Approx. 10 % of total body surface area
- Type of wrap if used: Surgical gauze held in place with semiocclusive self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Volume applied: 2.11 mL/kg bw
- Constant volume or concentration used: no

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Preliminary study: 1 male, 1 female at 2000 mg/kg bw
Main study: 4 male, 4 female at 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at 30 min, 1, 2 and 4 hrs after dosing
- Necropsy of survivors was performed
- Other examinations performed: clinical signs, body weight, organ weights.

Results and discussion

Preliminary study:

Mortality 0/2 animals.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the observation period

Clinical signs:

other: There were no signs of systemic toxicity

Gross pathology:

No abnormalities were detected during necropsy.

Other findings:

- There were no signs of skin irritation or corrosion.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The test substance was assessed for acute dermal toxicity according to OECD Guideline 402. The LD50 of the test material was >2000 mg/kg bw. The substance is therefore not classified.