reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 22, 1989 to July 17, 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

406-040-9

EC Name:

-

Cas Number:

125643-61-0

Molecular formula:

C24-26 H40-44 O3

IUPAC Name:

C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Details on test material:

Physical properties: yellow liquid, insoluble in water
Storage conditions: room temperature
Validity: May 1992
Test material received: May 18, 1989

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred and raisedon the premises of CIBA-GEIGY Ltd (CIBA-GEIGY Ltd, Animal Production, 4332 Stein, Switzerland)
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 177-213 g
- Fasting period before study: over night
- Housing: 5 animals per cage (segregated by sex) in Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet (e.g. ad libitum): Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switerzland) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h / 12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Doses:

2000 mg/kg bw (application volume was 10 mL/kg bw)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms: daily.
Body weight: immediately before administration and on days 7 and 14.
Necropsies: The animals were sacrificed and submitted to a gross necropsy at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities.

Mortality:

None.

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen (common symptoms in acute tests). The animals recovered within 6 days.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated,
where possible) was determined in rats of both sexes: greater than 2000 mg/kg body weight

Executive summary:

Sprague-Dawley rats of both sexes were treated by single gavage with 2000 mg/kg bw according to the OECD TG 401 (1987); treatment was followed by a 14 day post-treatment observation; at the end of this period the animals were sacrificed for the purpose of necropsy. No mortalities occurred. Common clinical symptoms including piloerection, hunched posture, and dyspnea were seen; the animals recovered within 6 days. Body weight was inconspicuous, Necropsy revealed no abnormalities. The LD50 for both sexes was > 2000 mg/kg bw.