9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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).

Preliminary study:

not applicable

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

One reliable study described in van Huygevoort (2003; OECD 423 (1996); GLP) is considered to be reliable without restrictions and is used as key study for this endpoint. The LD50 was determined to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity

The substance is not acutely toxic via the oral route based on an acute oral toxicity test (OECD 423) and does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.

Specific target organ toxicant (STOT) - single exposure: oral

Reversible or irreversible adverse health effects were not observed immediately or after exposure in an acute oral toxicity test (OECD 423). Thus, the classification criteria as specific target organ toxicant (STOT) – single exposure, oral are not met and the substance does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.