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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: No analytical certificate (no data on batch number and expiry date of the test substance), no data on GLP and experimental conditions. The very high tested dose enables a reliable conclusion.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl nitrate
EC Number:
248-363-6
EC Name:
2-ethylhexyl nitrate
Cas Number:
27247-96-7
Molecular formula:
C8H17NO3
IUPAC Name:
2-ethylhexyl nitrate
impurity 1
Chemical structure
Reference substance name:
2-ethylhexan-1-ol
EC Number:
203-234-3
EC Name:
2-ethylhexan-1-ol
Cas Number:
104-76-7
Molecular formula:
C8H18O
IUPAC Name:
2-ethylhexan-1-ol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Laboratory Supply Company, Indianapolis, Indiana
- Weight at study initiation: 200 to 275 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
10 mL/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:
Yes, but results were not indicated.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Mortality:
2 males and 1 female were found dead.
Clinical signs:
other: No clinical signs were observed.
Gross pathology:
No gross abnormalities were noted at necrospy.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 was expressed in mL/kg. The volume mass of the substance is 0.96 kg/L (0.96 g/mL). Therefore, when treating rats with 10 mL/kg, rats received 9.6 g/kg of substance, lowest limit of the LD50.