Soybean oil, epoxidized, Me ester, reaction products with propylene glycol

Endpoint summary

Description of key information

Acute toxicity (oral): LD50 > 30.0 mL/kg bw (corresponds to > 29.52 g/kg bw)

Acute toxicity (dermal): LD50 > 9.0 mL/kg bw (corresponds to > 8.856 g/kg bw)

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:

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

Qualifier:

equivalent or similar to guideline

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

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system 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

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:

Preliminary study:

not applicable

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:

other: 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.

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.

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)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

comparable to guideline study with acceptable restrictions

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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

Study period:

Jan 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Performed pre-GLP, method is described briefly (refer to the "principles of method" field)

Principles of method if other than guideline:

- Short description of test conditions: Dermal application of Nourypol 200 at dose levels of 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- Parameters analysed / observed: growth, food and water intake and haematology, as well ass Gross examination at autopsy

GLP compliance:

no

Remarks:

Prior to GLP adoption

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Not Specified

Species:

rabbit

Strain:

other: Albino

Remarks:

No further specification regarding the strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not specfied

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight

Duration of exposure:

Not specified

Doses:

0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight

No. of animals per sex per dose:

Not specified

Control animals:

yes

Remarks:

The 0.0 ml/kg body weight (control) dosed group was used as control

Details on study design:

- Frequency of observations and weighing: Haeatological data was obtained 2 weeks after a single dermal appliaction. other observation frequencies are not specified.
- Necropsy of survivors performed: yes
- Other examinations performed: growth, food and water intake, haematology, gross examination

Statistics:

not specified

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 9 mL/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: slight skin effects at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg.

Gross pathology:

Gross examination at autopsy did not reveal any clearly treatment-related changes

Interpretation of results:

other: Not classified

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

An acute dermal toxicity study with "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was performed in a study similar to OECD TG 402, pre-GLP, scored Klimisch 2.

"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested at 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight in albino rabbits. Duration of observation period following administration: 14 days, growth, food and water intake, haematology and gross pathology were examined. No mortality occurred, slight skin effects were seen at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg. Gross examination at autopsy did not reveal any clearly treatment-related changes. Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute toxicity.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

comparable to guideline study with acceptable restrictions

Additional information

Acute Oral toxicity:

"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" 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. 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)

Acute Dermal Toxicity:

An acute dermal toxicity study with "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was performed in a study similar to OECD TG 402, performed pre-GLP, scored Klimisch 2. "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested at 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight in albino rabbits. Duration of observation period following administration: 14 days, growth, food and water intake, haematology and gross pathology were examined. No mortality occurred, slight skin effects were seen at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg. Gross examination at autopsy did not reveal any clearly treatment-related changes. Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the available data, "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).