1-Tetradecanaminium, N,N,N-trimethyl-, ethanedioate (2:1)

Endpoint summary

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:

2004-02-17 to 2004-03-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented guideline conform, scientific GLP report

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH; Gartenstrasse 27; D-33178 Borchen, Germany
- Age at study initiation: 6-10 Weeks
- Weight at study initiation: 195g ± 8.9 g
- Fasting period before study:
- Housing:
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes, at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3°C
- Humidity (%): 50 ±20%
- Air changes (per hr): n.a.
- Photoperiod: 12 hrs dark/12hrs light

IN-LIFE DATES: From: 2004-02-17 To: 2004-03-02

Route of administration:

oral: gavage

Vehicle:

water

Doses:

300 and 2000 mg/kg body weight

No. of animals per sex per dose:

2000 mg/kg body weight: 3 (start dose)
300 mg/kg body weight: 6

Control animals:

no

Details on study design:

The prepared test substance was administered by gavage to fasted animals at the stated dosage.
The observation period following treatment lasted for 14 days.
Symptoms and lethality were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays
only once.
During this time the animals were weighed weekly.
Animals found dead were dissected as soon as possible and examined for macroscopically visible changes.
At the end of the observation period surviving animals were killed by carbon dioxide asphyxiation, dissected and
also examined for macroscopically visible changes

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

> 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: According to OECD guideline 423 the LD50 cut-off value is 500 mg/kg body weight.

Mortality:

at 300 mg/kg body weight: 2/6
at 2000 mg/kg body weight: 3/3

Clinical signs:

other: At 2000 mg/kg bw The following clinical signs were observed in the female animals starting between 10 and 30 minutes after the administration of the test substance: squatting posture, stilted, uncoordinated and ataxic gait, forward crawling, prone positi

Gross pathology:

At 2000 mg/kg bw:
Necropsy of one decedent animal revealed diffuse reddening in mucous membranes of stomach and small intestine. Another decedent animal revealed additionally orange discolored lungs, small intestines filled with green mucous as well as stomach filled with gas.
At 300 mg/kg bw:
Necropsy of the decedent animals revealed orange discolored lungs, as well as diffuse reddening of mucous membranes in stomach and small intestine. One decedent animal showed additional small intestines filled with green mucous and stomach filled with gas.
The animals killed at the end of the observation period showed no macroscopically visible changes.

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results obtained in this study with female rats the median lethal dose value (LD50) of the test substance lies between 300 and 2000 mg/kg body weight.
The LD50 cut-off value is 500 mg/kg body weight according to OECD guideline 423.

Executive summary:

In order to determine the acute oral toxicity of the test substance an acute oral toxicity test according to OECD Guideline 423 was performed in female rats. The solid test substance was solved in water and applied once by oral intubation. Observation period was 14 days. The starting dose of 2000 mg/kg body weight was choosen for 3 animals. Due to mortality seen in all 3 animals of that dose level within 1 to 4 hours after treatment, 300 mg/kg body weight was choosen for the next level. Two rats out of 6 rats of this dose group were found dead (i.e. at day 3 and day 6).

The acute oral toxicity testing of the test substance in the female rat yielded the following median lethal dose (LDso):

300< LD50 < 2000 mg/kg body weight. According to OECD guideline 423 the LD50 cut-off value is 500 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

500 mg/kg bw

Quality of whole database:

Reliable without restrictions.

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

In order to determine the acute oral toxicity of the test substance an acute oral toxicity test according to OECD Guideline 423 was performed in female rats. The solid test substance was solved in water and applied once by oral intubation. Observation period was 14 days. The starting dose of 2000 mg/kg body weight was choosen for 3 animals. Due to mortality seen in all 3 animals of that dose level within 1 to 4 hours after treatment, 300 mg/kg body weight was choosen for the next level. Two rats out of 6 rats of this dose group were found dead (i.e. at day 3 and day 6).

Based on the results obtained in this study with female rats the median lethal dose value (LD50) of the test substance lies between 300 and 2000 mg/kg body weight.

The LD50 cut-off value is 500 mg/kg body weight according to OECD guideline 423.

Justification for selection of acute toxicity – oral endpoint
Well documented guideline conform, scientific GLP report

Justification for classification or non-classification

According to Regulation No. 1272/2008 of the European Parliament and of the Council of Dec.2008 the test substance has to be classified for Acute toxicity Category 4.