Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Performed pre-GLP, using a method similar to OECD 401

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Performed pre-GLP, method is described clearly (refer to the "principles of method" field)
Principles of method if other than guideline:
- Principle of test: test material was given undiluted by gavage to groups of 10 males and 10 females in one single dose of 30 ml per kg body weight. After treatment the rats received stock diet and tap water ad libitum. The animals were observed for signs of intoxication during a 14-day period after which autopsies were carried out on the survivors.
- Short description of test conditions: The rats were housed in groups of five in screen·bottomed stainless steel cages, in a well-ventilated room, maintained at 23 ~ 1° C. Before dosing, the rats were fasted overnight. The test material was given undiluted by gavage.
- Parameters analysed / observed: signs of intoxication, deaths, gross pathology
GLP compliance:
no
Remarks:
Prior to GLP
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The Central Institute for the Breeding of Laboratory Animals, TNO, Zeist, The Netherlands
- Age at study initiation: Indicated as "young"
- Weight at study initiation: The body weights of the males varied from 170 to 198 g, those of females from 155 to 211 g.
- Fasting period before study: Overnight
- Housing: housed in groups of five in screen·bottomed stainless steel cages, in a well-ventilatedroom
- Diet: stock diet ad libitum
- Water: tab water at libitum

ENVIRONMENTAL CONDITIONS
Temperature: 23 +/- 1 C

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 30 ml per kg body weight. This dose is considered to be the highest tolerable amount to be given in one single oral dose.
Doses:
One single dose of 30 ml per kg
No. of animals per sex per dose:
10 males, 10 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:
not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 30 mL/kg bw
Based on:
test mat.
Mortality:
Out of 10 males and 10 females; 3 males and 2 females succumbed. Deaths occured between 4 hours and 2 days after dosing.
Clinical signs:
During the first few hours after dosing none of the rats showed any reaction to the treatment. Later on sluggishness, wet fur and emaciation were observed.
Body weight:
not specified
Gross pathology:
Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alterations.
Other findings:
The surviving animals recovered gradually and appeared healthy at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
Based on the result of this study the LD50 was > 30.0 mL/kg bw (which corresponds to > 29,52 g/kg bw), Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol therefore does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

Nourypol was tested for acute oral toxicity in a study similar to OECD TG 401, performed pre-GLP, scored Klimisch 2. A single 30.0 mL/kg bw dose of "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was administered by oral gavage to 10 male and 10 female Wistar rats. The animals were observed for 14 days while food and water were available ad libitum. During the first few hours after dosing none of the rats showed any reaction to the treatment. Later on sluggishness, wet fur and emaciation were observed. Mortality was observed in 5/20 rats (3 male and 2 female). The oral LD50 value of "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" in rats was established as > 30.0 mL/kg bw (which corresponds to > 29,52 g/kg bw). Under the conditions of this study, the substance does not have to classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)