bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993/04/01 to 1993/04/19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substances Act Regulations (16 CFR 1500.3)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate

EC Number:

700-897-5

Molecular formula:

C40H76O4

IUPAC Name:

bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 300g
- Age: 6 to 9 weeks old
- Fasting period before study: overnight
- Housing: stainless steel with indirect bedding
- Diet (e.g. ad libitum): Wad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at lease 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-75
- Humidity (%): mopnitored
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

dosed at 5g/kg

Doses:

5g/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 3, 6 and 24 h posting disage. Observations were made at least once daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: All animals appeared ruffled after 3 hours. Diarrhea and urine staining of the genitalia was observed over the next 24 - 72 hours. The animals appeared essentially recovered after 4 days.

Gross pathology:

No treatment related effects

Any other information on results incl. tables

Body Weight Data

Day 1	Day 14
288	420
235	320
209	322
200	314
222	338
227	270
244	286
234	274
252	282
224	268

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is > 5000 mgkg

Executive summary:

Test Guidance

Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations.

Method and Material

A group of ten (5 male and 5 female) Wistar rats were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals.

Results

The test material gave an LD50> 5000 mg/kg bw. There were no mortalities. All animals gained weight as expected during the 14 day observation period.

Conclusion

The substance is not classified in accordance with CLP Regulation (EC) No 1272/2008..