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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

1
Chemical structure
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.

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