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Diss Factsheets

Administrative data

Description of key information

Oral (Rat-Wistar, GLP, OECD TG 401): LD50 > 2000 mg/kg
[Bayer AG, Report No. PH-18819, 1990-02-20]
Inhalation (Rat-Wistar, GLP, OECD TG 403, EU Method B.2, OPPTS 870.1300): LC50 > 4575 mg/m³
[Bayer AG, Report No. PH-34479, 2006-06-01]

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jun-Jul 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
tap water
Doses:
2000 mg/kg with an administration volume of 20 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

No deaths occurred as well as no deviations in weight development. 15 minutes to 2 hours after application piloerection was observed in all males, females showed no clinical signs.No gross pathological findings at sacrifice were observed.

Executive summary:

The acute oral toxicity to male and female Wistar rats of N-Formylaminosorbit was assessed. The test compound was formulated in tap water, the administration volume was 20 ml/kg body weight. No deaths occurred as well as no deviations in weight development. 15 minutes to 2 hours after application ruffled fur was observed in all males, females showed no clinical signs.No gross pathological findings at sacrifice were observed.

Therefore, the LD50 of N-Formylaminosorbit in male and female rats is above 2000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb-Mar 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Remarks:
dynamic exposure conditions
Vehicle:
other: the test article was aerolized as dry powder
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric evaluation
Duration of exposure:
4 h
Concentrations:
target: 5000 mg/m³
gravimetric concentration: 4575.0 mg/m³
No. of animals per sex per dose:
5
Control animals:
yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4 575 mg/m³ air
Exp. duration:
4 h

The 4575 mg/m³ aerosol was inhalable; the mass median aerodynamic diameter (MMAD) was 6.51 µm with a geometric standard deviation of 2.30.

No mortalities occurred as well as no clinical signs, no changes in body weight development and no necropsy findings. Exposed male rats revealed a slight but significant decrease of body temperature.

Executive summary:

The acute inhalation toxicity of N-Formylaminosorbit was investigated in male and female Wistar rats. The animals were nose-only exposed for 4 h to a maximum attainable mean solid aerosol concentration of 4575.0 mg/m³ (powder) air. The 4575 mg/m³ aerosol was inhalable; the mass median aerodynamic diameter (MMAD) was 6.51 µm with a geometric standard deviation of 2.30.

No mortalities occurred as well as no clinical signs, no changes in body weight development and no necropsy findings. Exposed male rats revealed a slight but significant decrease of body temperature.

Therefore, the LC50 inhalation (aerosol, 4 h) is above 4575 mg/m³ whereas the NO(A)EL is below 4575 mg/m³.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of N-Formylaminosorbit was studied in male and female rats.

The acute oral LD50 was determined to be > 2000 mg/kg.

The acute inhalation toxicity of N-Formylaminosorbit was studied in male and female rats.

The LC50 inhalation (aerosol, 4 h) was determined to be > 4575 mg/m³ (the maximum attainable mean solid aerosol concentration).


Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for selection of acute toxicity – inhalation endpoint
only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.