9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-12-02 to 2003-03-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996-03-22

Deviations:

yes

Remarks:

rationale for the selection of the starting dose is missing

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester

EC Number:

608-605-7

Cas Number:

313482-99-4

Molecular formula:

C22H26O5Si

IUPAC Name:

9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester

Test material form:

solid

Details on test material:

- State of aggregation: yellow mass (frozen melt)

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: males: 311 ± 12 g; females: 204 ± 3 g
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance.
- Housing: group housing of 3 animals/sex/cage in Macrolon cages (type IV; height 18
cm.) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Diet (ad libitum): standard pelleted laboratory animal die! (from Allromin (code VRF 1 ), Lage, Germany)
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 30 - 70%
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

DOSAGE PREPARATION:
The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. The formulations were heated to 50°C and allowed to cool down until 36 - 38 °C prior to dosing.

VEHICLE
- Justification for choice of vehicle: the vehicle was selected based on trial formulations performed at the laboratory.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males / 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
a) Mortality/Viability: twice daily
b) Body weights: days 1 (pre-administration), 8 and 15
c) Clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1 ).

- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed and subjected to necropsy.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

Hunched posture, uncoordinated movements, paresis, paresis of the forelegs, piloerection, chromodacryorrhoea and/or ptosis were noted among the females between days 1 and 3.
Lethargy was noted in one female on day 7.
Uncoordinated movements, abnormal gait and/or abnormal posture (of forelegs and hindlegs) were noted among the males belween days 1 and 5.

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to !hat expected of normal untreated animals of the same age and strain.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.