Octadecanoic acid, reaction products with triethylenetetramine, chloromethane-quaternized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Octadecanoic acid, reaction products with triethylenetetramine, chloromethane-quaternized

EC Number:

291-716-4

EC Name:

Octadecanoic acid, reaction products with triethylenetetramine, chloromethane-quaternized

Cas Number:

90459-71-5

Molecular formula:

Not applicable - UVCB substance

IUPAC Name:

Octadecanoic acid, reaction products with triethylenetetramine, chloromethane-quaternized

Test material form:

solid

Test animals

Species:

rat

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: no
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Step 1: 144 – 153 g; Step 2: 169 – 188 g
- Fasting period before study: food was withheld from the test animals for 16 to 19 hours (access to water was permitted)
- Artificial light, sequence being 12 hours light, 12 hours dark
- Housing: Full barrier in an air-conditioned room
- Diet/water: Free access to Altromin 1324 maintenance diet for rats and mice. Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: - Adequate acclimatisation period (at least five days) under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test item was suspended with the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL
- Amount of vehicle (if gavage): The test item was administered at a dose volume of 10 mL/kg body weight.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
The starting dose was selected to be 2000 mg/kg body weight. Compound related mortality was recorded for 1 animal of step 1. Based on these results and according to the acute toxic class method regime, a second step was performed at a dose of 2000 mg/kg body weight. No compound related mortality was recorded for any animal of step 2. Based on these results and according to the acute toxic class method regime no further testing was required.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Mortality:

One animal of step 1 treated with the test item at a dose of 2000 mg/kg had to be sacrificed for animal welfare reasons on study day 2. All remaining animals survived until the end of the study (including the animals of step two).

Clinical signs:

The most relevant clinical findings in these animals were: reduced spontaneous activity, piloerection, hunched posture, piloerection, half eyelid-closure, eyes closed, abnormal breathing, prone position and wasp waist. The two remaining animals recovered within 2 days post-dose

Body weight:

None of the animals showed weight loss during the observation period

Gross pathology:

No specific gross pathological changes were recorded in the surviving animals.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 cut-off value determined for the substance settles down at 2500 mg/kg bw. This concentration falls in the range of Category 5 for Classification on Oral Acute Toxicity (2000 - 5000 mg/kg bw). For CLP purposes of classification, the substance doesn't result classified for Acute Toxicity.