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Description of key information

Data from the corresponding acid has been used to satisfy the endpoint for the acid anhydride.

The acute oral toxicity of the test item is very low with an LD50 value of 4600 mg/kg bw in male and female rats. The test item was administered as solution in olive oil ( 2150, 3160, 4640, 6810 mg/kg bw). Mortality and gross pathological findings were restricted to the animals treated with 4640 and 6810 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test to determine acute oral toxicity in rats
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Extertal, Germany
- Mean weight at study initiation: males: 195 g, females 193 g
- Fasting period before study: no data
- Diet: Herilan MRH ad libitum
- Water: tap water ad libitum
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
VEHICLE
- Concentration in vehicle: 10, 21.5, 31.6, 46.4 and 50 %
Doses:
2150, 3160, 4640, 6810 mg/kg bw
No. of animals per sex per dose:
10 animals (5 males, 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis (Finney)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
Based on:
test mat.
Mortality:
Males /females:
6810 mg/kg bw: 4/5 out of 5
4640 mg/kg bw: 2/4 out of 5
at lower dose levels no death occurred
Clinical signs:
irregular respiration, apathy, abdominal position, staggering, atony, narcosis-like state, absent pain reflex, piloerection, diarrhea, exsiccosis, bloody excrements; local signs of irritation, salivation, bad general condition
Gross pathology:
4640 and 6810 mg/kg dosing groups: acute dilatation of the right ventricle, gastritis, local adhesions of stomach and liver;
2150 and 3160 mg/kg dosing groups: organs without findings
Other findings:
not applicable

Results of the preliminary study involving 3 males and 3 females per dosing group: 1000 mg/kg bw. 0/2 females died 2000 mg/kg bw: 3/3 males and 2/3 females died 4000 mg/kg bw: no death occurred within the study period of 14 days. The preliminary study was conducted under the same conditions as the main study. Clinical signs of toxicity are comparable to the clinical signs observed in the main study. No other signs of toxicity were observed.

Interpretation of results:
other: not classified
Conclusions:
The acute oral LD50 for male and female rats was 4600 mg/kg.
Executive summary:

The acute oral toxicity of the test item is very low with an LD50 value of 4600 mg/kg bw in male and female rats. The test item was administered as solution in olive oil ( 2150, 3160, 4640, 6810 mg/kg bw). Mortality and gross pathological findings were restricted to the animals treated with 4640 and 6810 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The use of pentanoic acid as surrogate for pentanoic acid is based on the fact that the anhydride undergoes hydrolysis to the corresponding acid (see chapter 5.1.2). In particular with regard to oral administration pentanoic anhydride is considered to be hydrolysed fast and fully in the range of minutes due to the low local pH-value in the stomach.
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
Based on:
test mat.
Mortality:
Males /females:
6810 mg/kg bw: 4/5 out of 5
4640 mg/kg bw: 2/4 out of 5
at lower dose levels no death occurred
Clinical signs:
irregular respiration, apathy, abdominal position, staggering, atony, narcosis-like state, absent pain reflex, piloerection, diarrhea, exsiccosis, bloody excrements; local signs of irritation, salivation, bad general condition
Gross pathology:
4640 and 6810 mg/kg dosing groups: acute dilatation of the right ventricle, gastritis, local adhesions of stomach and liver;
2150 and 3160 mg/kg dosing groups: organs without findings
Other findings:
Not applicable
Interpretation of results:
other: not classified
Conclusions:
The acute oral LD50 for male and female rats was 4600 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 600 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the data for surrogate no classification for acute oral toxicity according to Regulation (EC) No. 1272/2008 (CLP) is required for pentanoic anhydride.