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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Jul - 11 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted in 2002
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1)
EC Number:
241-727-5
EC Name:
(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1)
Cas Number:
17736-08-2
Molecular formula:
C21H39NO3.C6H15NO3
IUPAC Name:
(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1)
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Wistar Crl:WI (Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 167 - 198 g
- Fasting period before study: animals were fasted overnight prior to dosing and until 3 - 4 h after administration of the test item
- Housing: animals were housed in groups of 3 per cage in labelled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6.36 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Two groups of 3 females each
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/viability was recorded twice daily, clinical examination was made several times on the day of dosing and once daily thereafter, weighing was performed prior to application and weekly thereafter
- Necropsy of survivors performed: yes (at the end of the observation period)
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: according to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg bw
Mortality:
1/6 females was found dead on Day 3 of the study period.
Clinical signs:
other: Hunched posture and/or piloerection were noted for the animals between Days 1 and 3. Additionally, lethargy, flat posture, slow breathing, shallow respiration and hypothermia were noted for the animal found dead on Days 1 and/or 2.
Gross pathology:
No toxicologically relevant abnormalities were found at macroscopic examination of the animals.

Any other information on results incl. tables

Table 1: Summary of mortality/clinical signs in female rats

Dose [mg/kg bw]

Mortality

Clinical signs

N*

N*

2000

1/6

6/6

*N= Number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
In this acute oral toxicity study in female rats a LD50 value greater than 2000 mg/kg bw was determined.

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