2,4-di-tert-pentylphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2,4-di-tert-pentylphenol

EC Number:

204-439-0

EC Name:

2,4-di-tert-pentylphenol

Cas Number:

120-95-6

Molecular formula:

C16H26O

IUPAC Name:

2,4-bis(2-methylbutan-2-yl)phenol

Details on test material:

- Name of test material (as cited in study report): 2,4-di-tert-Amylphenol
- Physical state: liquid
- Analytical purity: 99.61%
- Purity test date: 1998-01-28
- Lot/batch No.: not mentioned
- Date of production: 1998-01-14
- Stability under test conditions: > 1 year
- Storage condition of test material: in tightly closed containers, under exhaust hood

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young healthy adults, no further details mentioned
- Weight at study initiation: the weight variation did not exceed ± 20% of the mean body weight (deviation: three male animals were not within the weight range; they weighed +22%, -27% and -21%)
- Fasting period before study: 16 hours
- Housing: 3 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

No. of animals per sex per dose:

200 and 500 mg/kg: 3 male and 3 female
2000 mg/kg: 3 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 7 and 14 days after treatment and on the day of death.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

No

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

500 - 2 000 mg/kg bw

Mortality:

2000 mg/kg bw: Two animals died 72 h after application and one animal was killed on day 7.

Clinical signs:

200 mg/kg bw: There were no signs of sytemic reaction after treatment.
500 mg/kg bw: The animals showed piloerection and diarrhea on the day of treatment.
2000 mg/kg bw: All animals showed severe clinical symptoms after treatment, sedation staggering, increased activity, squatting position, gait abnormality (ataxia), chromodaxryorrhea, piloerection, hypothermia, diarrhea, loss of weight, emaciation, blood tinged front feet and slow breathing were noticed.

Body weight:

200 mg/kg bw: On day 4, all female animals showed little bodyweight loss. Apart from this all animals achieved satisfacrory bodyweigt gains throughout the study.
500 mg/kg bw: Little bodyweight loss was noticed on day two in all animals and on day 1 in two females and on day 6 in one female animal. At the end of the study a satisfactory bodyweight gain was achieved in all animals.
2000 mg/kg bw: All animals showed severe body weight loss before death.

Gross pathology:

200 mg/kg bw: Similar findings were noticed in male and female animals. The gastric mucosa showed general or focal thickening of the gastric wall.
500 mg/kg bw: The gastric mucosa of all showed general or focal thickening of the gastric wall.
2000mg/kg bw: A

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU