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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

Constituent 1
Chemical structure
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..