SDBR

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb- April 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Version / remarks:

1991

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:

424-970-3

EC Name:

-

Cas Number:

166255-23-8

Molecular formula:

C16-H14-O3.C6-H16-O3-Si

IUPAC Name:

Triethoxysilylpropyl Dibenzoyl Resorcinol

Test material form:

solid

Details on test material:

Color: Light beige

Specific details on test material used for the study:

Stability: stable
Solubility: in toluene, methylene chloride
Insoluble: in water
Storage conditions: room temperature

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA, USA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 49 to 74 days old
- Weight at study initiation: 221.9-249.4g (males), 201.3-216.9g (females)
- Fasting period before study: yes, o/n prior to dosing
- Housing: group housed in polycarbonate cages with hardwood chips as contact bedding
- Diet: commercial rodent feed (AgWay Prolab, Waverly, NY), ad libitum
- Water: municipal tap water, ad libitum
There were no known contaminants present in the feed, bedding, or water expected to interfere with the test data.
- Acclimatization period: 6 days

ENVIRONMENTAL CONDITIONS (SET CONDITIONS)
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): minimum 10-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 March 1994 To: 13 April 1994

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: <10 mL/ kg bw

DOSAGE PREPARATION:
The test substance was suspended in corn oil and placed at 70ºC for 60 minutes to allow the test substance to melt. The suspension was cooled at room temperature and the suspension was continuously stirred during the dosing period.

Doses:

Total dose: 5000 mg/kg bw (animals were dosed twice within a period of 4 hours)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were weighed on Day 7 and on Day 14 prior to sacrifice. At the end of the study, the animals were sacrificed by CO2 inhalation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No animals died at this dose level during the observation period.

Clinical signs:

other: No signs of toxicity were noted throughout the study.

Gross pathology:

No unusual lesions were noted in any of the animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an acute oral toxicity study in male and female rats, the LD50 was found to exceed 5000 mg/kg bw.