Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Toxicity of methyl 5-nitrohydrogen.isophthalate in any of the routes have to been distinctly observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
1 387.52 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Data is from RTECS database
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Doses:
>16 gm/kg
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 other: gm/kg
Remarks on result:
other: Toxic effects: Liver - fatty liver degeneration Kidney/Ureter/Bladder - other changes.
Mortality:
50 percent kill
Clinical signs:
other: Toxic effects: Liver - fatty liver degeneration Kidney/Ureter/Bladder - other changes.
Conclusions:
The LD50 for chemical 3-(methoxycarbonyl)-5-nitrobenzoic acid was determined to be >16 gm/kg when exposed to male/female rats orally.
Executive summary:

The LD50 for chemical 3-(methoxycarbonyl)-5-nitrobenzoic acid was determined to be >16 gm/kg when exposed to male/female rats orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
16 000 mg/kg bw

Additional information

Acute oral toxicity:

Oral toxicity (LD50) Rat for 2-(2-ethoxyethoxy) ethyl acetate was examined at dose concentration of 11000 mg/kg of body weight. This value suggests that the chemical does not exhibit acute toxicity through the oral route.

Acute inhalation toxicity:

A reliable handbook source Patty's Toxicology indicated that Rats and guinea pigs exposed to essentially saturated atmospheres of test substance at room temperature for 8 h all survived, although injury to the lungs and kidneys was observed at necropsy.

Acute dermal toxicity:

The LD50 for chemical 3-(methoxycarbonyl)-5-nitrobenzoic acid was determined to be >16 gm/kg when exposed to male/female rats orally.

Justification for classification or non-classification

The LD 50 values for 2-(2-ethoxyethoxy) ethyl acetate suggest that the substance will not be classified in any of the acute toxicity categories as per the C & L criteria set by EU.