Tridecanamine, N-tridecyl-, branched and linear

Endpoint summary

Description of key information

LD50, rat oral = 2700 mg/kg bw (BASF 1970)

In two supporting studies, no mortality was observed at the limit dose of 2000mg/kg in rats.

IRT, rat: saturated vapour caused no mortality

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Gassner

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: 0.1 - 30% emulsion with traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.1-30% emulsion with tragacanth gum

MAXIMUM DOSE VOLUME APPLIED:
6400 mm3/kg

Doses:

200, 1600, 2000, 2500, 3200, 4000, 5000, 6400 mm³/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 700 mg/kg bw

Remarks on result:

other: Original data: 3300 mm³/kg

Mortality:

200 mm3/kg bw group: no deaths occurred
1600 mm3/kg bw group: 1/10 males died, no females died
2000 mm3/kg bw group: no males died, 3/10 females died
2500 mm3/kg bw group: 1/10 males died, 6/10 females died
3200 mm3/kg bw group: 1/10 males died, 8/10 females died
4000 mm3/kg bw group: 6/10 males died, 10/10 females died
5000 mm3/kg bw group: 6/10 males died, 10/10 females died
6400 mm3/kg bw group: 10/10 males died, 10/10 females died

Clinical signs:

other: Dyspnea, apathy and diarrhea

Gross pathology:

Sporadically, considerable injection of the gastric vessels

Interpretation of results:

Category 5 based on GHS criteria

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

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)

Principles of method if other than guideline:

In an acute oral toxicity study performed according to the Acute Toxic Class Method, a dose of 2000 mg/kg bw of the undiluted test item Tridecanamine, N-tridecyl-, branched and linear (DTDA plus) was administered by gavage to two test groups of three fasted Wistar rats each (6 females).

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: [no]
- Age at study initiation: 10 weeks
- Weight at study initiation: Individual identification by cage cards and tail marking
- Fasting period before study: Yes
- Housing: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C  3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
- Diet (e.g. ad libitum): R/M maintenance, low phytoestrogen; Ssniff, Spezialdiäten GmbH, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days

Route of administration:

oral: gavage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted
- Amount of vehicle (if gavage): not reported
- Justification for choice of vehicle:not reported
- Lot/batch no. (if required): not reported

Doses:

2000 mg/kg

No. of animals per sex per dose:

2x (2000 mg/kg bw in 3 female)

Control animals:

no

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Clinical signs in the first 2000 mg/kg test group revealed in all animals impaired general state and piloerection at hour 0 after administration. Clinical signs in the second 2000 mg/kg test group revealed in all animals impaired general state and piloere

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of Tridecanamine, N-tridecyl-, branched and linear (DTDA plus) after oral administration was found to be greater than 2000 mg/kg bw in rats

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

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)

Principles of method if other than guideline:

In an acute oral toxicity study performed according to the Acute Toxic Class Method, a dose of 2000 mg/kg bw of the undiluted test item Tridecanamine, N-tridecyl-, branched and linear was administered by gavage to two test groups of three fasted Wistar rats each (6 females).

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: [no]
- Age at study initiation: 10 weeks
- Weight at study initiation: Individual identification by cage cards and tail marking
- Fasting period before study: Yes
- Housing: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C  3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study
- Diet (e.g. ad libitum): R/M maintenance, low phytoestrogen; Ssniff, Spezialdiäten GmbH, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days

Route of administration:

oral: gavage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted
- Amount of vehicle (if gavage): not reported
- Justification for choice of vehicle:not reported
- Lot/batch no. (if required): not reported

Doses:

2000 mg/kg

No. of animals per sex per dose:

2x (2000 mg/kg bw in 3 female)

Control animals:

no

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination in the first 2000 mg/kg bw. test group. Clinical signs in the second 2000 mg/kg bw test group revealed in all animals impaired general state and piloerection from study day 3 until day 10 after a

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of Tridecanamine, N-tridecyl-, branched and linear after oral administration was found to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion

Dose descriptor:

discriminating dose

Value:

2 700 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

BASF test (Inhalation hazard test)
The test was performed in priniple as described in OECD Guideline 403. The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temerature chosen for vapour generation (20°C). 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted gassdisc in a glass cylinder for 8h. The documentation of clinical signs was performed over a period of 7 days. In order toverify the results, the test was repeated once.

GLP compliance:

no

Test type:

other: Inhalation-risk test (IRT)

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

male/female

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature in air chamber: 20°C

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

no data

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Sex:

male/female

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: no mortality (saturated vapour concentration)

Mortality:

No mortality was observed.

Clinical signs:

other: Moderate irritation to the mucosa.

Gross pathology:

No abnormalities detected.

Interpretation of results:

study cannot be used for classification

Additional information

Oral toxicity

In an acute oral toxicity study comparable to OECD 401, Gassner rats (10/sex/dose) were administered di-tridecamine at 200, 1600, 2000, 2500, 3200, 6400 mm3/kg (equivalent to ca. 164 to 5236 mg/kg) by single dose (gavage) followed by a 7 -day observation period (BASF AG, 1970). Clinical signs included dyspnoea, apathy and diarrhea. Gross pathology reported diarrhea and atonic intestine in animals that died at and above 1600mg/kg, but no ulceration or bloody content. Above 3000mg/kg, injection of vessels in the stomach was observed. The LD50 was 2700 mg/kg bw.

 

In addition, two oral toxicity studies of Tridecanamine, N-tridecyl-, branched and linear were conducted (2018, GLP) to compare the toxicological properties of two batches of the UVCB DTDA (PSN 18/0020 -1 and PSN 18/0019 -1)

In both studies, the limit dose of 2000mg/kg was administered to a total of 12 rats by gavage, followed by a 14 -day observation period. No mortality occured with either batch. Clinical signs were limited to impaired general state and piloerection and occured in most rats. Weight gain was only transiently affected in 3 rats, and gross pathology revealed no abnormalities. In conclusion, the LD50 was > 2000mg/kg for both batches.

Inhalation toxicity

In a study in which rats were exposed to a saturated di-tridecamine atmosphere at 20°C, no deaths were observed during a 7 -day observation period after 8 hours of exposure (BASF AG, 1970). Due to the very low vapour pressure of the test substance (< 0.00001 Pa), the exposure concentration will also have been very low.

Justification for classification or non-classification

Based on the results of the acute toxicity studies, di-tridecamine does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.