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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-ethylhexyl)isononan-1-amide
EC Number:
298-613-3
EC Name:
N-(2-ethylhexyl)isononan-1-amide
Cas Number:
93820-33-8
Molecular formula:
C17H35NO
IUPAC Name:
N-(2-Ethylhexyl)isononan-1-amide
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Age at study initiation: male animales 7 weeks, female animals 8 weeks
- Weight at study initiation: male animales 186 +/- 3 g; female animals 176 +/- 5 g
- Fasting period before study: over night
- Housing: macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg body weight (limit dose)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopic pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities and no clinical signs of toxicity observed
Mortality:
No mortality
Clinical signs:
other: No clinical signs of intoxication
Gross pathology:
No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item in rats is greater 2000 mg/kg body weight. At this limit dose no mortality and no clinical signs of intoxication were observed in the 14 day observation period following oral application.
Executive summary:

The registration substance was tested for acute oral systemic toxicity in male and female Wistar rats. After application of 2000 mg/kg body weight (limit dose), no mortality and no clinical signs of intoxication occurred within the subsequent observation period of 14 days. Macroscopically visible changes were not observed during necropsy. Based on the results of this study the median lethal dose (LD50) of the registration substance in the rat is greater than 2000 mg/kg body weight.