4-dimethylaminobenzaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 22, 2016 - January 18, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-dimethylaminobenzaldehyde

EC Number:

202-819-0

EC Name:

4-dimethylaminobenzaldehyde

Cas Number:

100-10-7

Molecular formula:

C9H11NO

IUPAC Name:

4-(dimethylamino)benzaldehyde

Test material form:

solid

Specific details on test material used for the study:

Designation: Art. 803057
Synonym: 4-(Dimethylamino)benzaldehyde
CAS-No.: 100-10-7
Batch: S6886257
Purity (GC, area%): 99.6% (a/a)
Appearance: Grey-blue, crystalline powder
Released until: May 31, 2019
Storage: Tightly closed, dark at room temperature (15 to 25°C)



TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item preparation was made directly before administration. Appropriate amounts of the test item were suspended in the vehicle using a spatula, a mini shaker (Vortex Genie 2®, Scientific Industries Inc, New York, USA), Ultra-Turrax device (Ultra-Turrax T25, IKA®-Werke GmbH & Co. KG, Staufen, Germany) and a magnetic stirrer. The test item preparation was administered within less than 1 hour after preparation. The stability of the test item in the vehicle was not investigated.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at start of study: 9 weeks
- Weight at study initiation: 154 - 183g
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 22.9°C
- Humidity (%): 47.5-73.0%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 g/L and 200 g/L
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

6 (f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was seen after treatment with 300 mg/kg. One rat treated with 2000 mg/kg was killed in moribund condition 4 hours after treatment. All other rats treated with 2000 mg/kg survived the observation period.

Clinical signs:

other: No clinical signs of toxicity were observed after treatment with 300 mg/kg. The rat killed in moribund condition after treatment with 2000 mg/kg showed locomotor disturbance, dyspnoea, piloerection, abdominal position and salivation. The surviving rats tr

Gross pathology:

The gross pathological examination of rats dosed with 300 and 2000 mg/kg revealed no organ alterations that could be related to treatment. The examination of one prematurely killed animal dosed with 2000 mg/kg revealed no lesions that could be related to treatment with the test material.

Any other information on results incl. tables

Objective

The objective of the present study was to identify potential toxic effects of the test item, Art. 803057 (4-(Dimethylamino)benzaldehyde) after single oral administration to rats in a stepwise procedure.

Study Design

The study was started with 300 mg/kg in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg/kg,
6 further females were treated with 2000 mg/kg.

Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.

Results

No mortality was seen after treatment with 300 mg/kg. One rat treated with 2000 mg/kg was killed in moribund condition 4 hours after treatment. All other rats treated with 2000 mg/kg survived the observation period.

No clinical signs of toxicity were observed after treatment with 300 mg/kg. The rat killed in moribund condition after treatment with 2000 mg/kg showed locomotor disturbance, dyspnoea, piloerection, abdominal position and salivation. The surviving rats treated with 2000 mg/kg showed locomotor disturbance on day one of the experimental phase, which started 15 minutes after treatment.

The body weight development was inconspicuous throughout the study.

The gross pathological examination of rats dosed with 300 and 2000 mg/kg revealed no organ alterations that could be related to treatment. The examination of one prematurely killed animal dosed with 2000 mg/kg revealed no lesions that could be related to treatment with the test material.

Conclusion

After treatment with 2000 mg/kg of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) some clinical symptoms were seen and one female rat was killed in moribund condition. However, the LD₅₀ value is higher than 2000 mg/kg after single oral administration in female rats.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After treatment with 2000 mg/kg of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) some clinical symptoms were seen and one female rat was killed in moribund condition. However, the LD50 value is higher than 2000 mg/kg after single oral administration in female rats.

Executive summary:

This study was performed according to GLP and is fully compliant with OECD TG 423. After treatment with 2000 mg/kg of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) some clinical symptoms were seen and one female rat was killed in moribund condition. However, the LD₅₀value is higher than 2000 mg/kg after single oral administration in female rats.