Registration Dossier
Registration Dossier
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EC number: 260-126-9 | CAS number: 56358-17-9
Acute Toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-(2-ethylhexyl)naphthalen-2-amine
- EC Number:
- 260-126-9
- EC Name:
- N-(2-ethylhexyl)naphthalen-2-amine
- Cas Number:
- 56358-17-9
- Molecular formula:
- C18H25N
- IUPAC Name:
- N-(2-ethylhexyl)naphthalen-2-amine
- Details on test material:
- - Name of test material (as cited in study report): N-(2-Ethylhexyl)-2-napthalinamin
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hagemann
- Weight at study initiation: males mean 170-220 g; females mean ca. 170 g
- Fasting period before study: 15-20 h before application
- Housing: no data
- Diet: Herilan MRH-Haltung, no further data
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 21.5, 31.6 and 46.4 %
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: none given
MAXIMUM DOSE VOLUME APPLIED:
10 ml/kg
- Doses:
- 2150, 3160, 4640 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, day 2-4, day 7, day 9-13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 014 mg/kg bw
- 95% CL:
- > 2 547 - < 3 553
- Mortality:
- at the 2150 mg/kg dose level, 1/5 females and 0/5 males died; at the 3160 mg/kg dose level, 3/5 males and 2/5 females died; at the 4640 mg/kg
dose level all male and all female animals died - Clinical signs:
- other: at 2150 mg/kg dose level: dyspnea, apathy, staggering, scrubby fur, diarrhea and bad general condition was observed at 3160 mg/kg dose level: dyspnea, apathy, staggering, spastic gait, scrubby fur, diarrhea, exsiccosis and bad general condition was observ
- Gross pathology:
- animals that died during the study: heart: acute dilation of the prechamber, acute congestive hyperemia; stomach: stuffed, isolated bloody ulcerations; gut: atonic, content dysenteric
sacrificed animals: without findings
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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