Registration Dossier
Registration Dossier
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EC number: 948-046-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 October 2017 to 26 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 Nousan No. 8147, 24 November 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
- Molecular formula:
- Not applicable
- IUPAC Name:
- Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
- Test material form:
- liquid
- Details on test material:
- CAS number: Not yet known
EC Number: Not yet known
Constituent 1
- Specific details on test material used for the study:
- Purity: >93%
Physical State/Appearance: Dark amber viscous liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- A sighting test using one animal, and additional four animals
- Control animals:
- no
- Details on study design:
- Following a sighting test at a dose level of 2000 mg/kg body weight in one fasted female animal, an additional four fasted female animals were given a single oral dose of the undiluted test item at a dose level of 2000 mg/kg body weight and followed with a 14-day observation period. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no unscheduled deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.
- Executive summary:
The study was performed to assess the acute toxicity of the test item following a single oral dose in the Wistar strain rat.
Following a sighting test at a dose level of 2000 mg/kg body weight in one fasted female animal, an additional four fasted female animals were given a single oral dose of the undiluted test item at a dose level of 2000 mg/kg body weight and followed with a 14-day observation period. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no unscheduled deaths and no signs of systemic toxicity. Based on historical data from the supplier for this strain, all animals showed expected gains in body weight over the observation period, except for one animal which showed an expected gain in body weight during the first week of the study but a slight body weight loss (-2.5%) during the second week. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.
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