Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Endpoint summary

Description of key information

No data on the test item is available. With the read-across substances the following results were obtained:

Acute oral, mouse (CAS 68583-51-7): EC50 > 4600 mg/kg

Acute inhalation, guinea pig (CAS 68583-51-7): LC50 > 200 ppm (equivalent to 5952 mg/m³)

Acute inhalation, rat (CAS 68583-51-7): LC50 > 200 ppm (equivalent to 5952 mg/m³)

Acute dermal, rat (CAS 853947-59-8): LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1972

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 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

other: White mice of Tylers original strain

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 20 ± 2 g
- Fasting period before study: overnight
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
no details available

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No details available

Doses:

5 mL/kg, which is correspondent to 4.6 mg/kg bw

No. of animals per sex per dose:

10 animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: after 1, 2, 3, 4, 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: no

Preliminary study:

Pretest: Concentrations: 1, 2, 3, 4 and 5 mL/kg, 2 animals each, observed for 7 days, no deaths observed

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 4 600 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of the test item in mice was established as exceeding 4600 mg/kg body weight.

Executive summary:

In an acute oral toxicity study, conducted similar to OECD 401, groups of fasted white mice were given a single oral dose of the test item at a dose of 5 mL/kg bw and observed for 14 days. No animals died during the study. No clinical signs were observed during the study period. The oral LD50 was determined to be > 5 mL/kg bw, which is correspondent to 4600 mg/kg bw.

Reference 2

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:

Please refer to Chapter 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 4 600 mg/kg bw

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

4 600 mg/kg bw

Quality of whole database:

similar to guideline study

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1987

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 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Species:

guinea pig

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: young
- Weight at study initiation: 285 - 465 g

Route of administration:

inhalation: mist

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Each group of guinea pigs was placed in a 75 liter chamber equipped with an air supply of 10 liters per minute. After the test animals became accustomed to the chamber conditions, the test item was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm. Particle counts were performed every 30 minutes using Bausch and Lomb particle counter (model 40-1A). The chamber temperature was recorded every 30 minutes. The control group was exposed to only air for the same length of time.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

6 h

Concentrations:

200 ppm (equivalent to 5952 mg/m³)

No. of animals per sex per dose:

200 ppm: 6 male, 6 female
control: 3 animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Mortality:

No animals died or were sacrificed in moribund condition.

Clinical signs:

other: No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period.

Gross pathology:

In the necropsies and microscopic examination no changes in the animals were detected, which could be related to the treatment.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation study on guinea pigs over 6h the LC50 was above 200 ppm (equivalent to 5952 mg/m³):

Executive summary:

An acute inhalation study on guinea pigs over 6h with the test item was performed. The concentration of 200 ppm was prayed into the air supply for 12 guinea pigs (6 male, 6 female). After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1987

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 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, New York
- Age at study initiation: young
- Weight at study initiation: 145 - 195 g

Route of administration:

inhalation: mist

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Each group of rats was placed in a 75 liter chamber equipped with an air supply of 10 liters per minute. After the test animals became accustomed to the chamber conditions, the test item was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm. Particle counts were performed every 30 minutes using Bausch and Lomb particle counter (model 40-1A). The chamber temperature was recorded every 30 minutes. The control group was exposed to only air for the same length of time.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

6 h

Concentrations:

200 ppm (equivalent to 5952 mg/m³)

No. of animals per sex per dose:

200 ppm: 10 male
control: 3 male

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Sex:

male

Dose descriptor:

discriminating conc.

Effect level:

200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Mortality:

No animals died or were sacrificed in moribund condition.

Clinical signs:

other: No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period.

Gross pathology:

In the necropsies and microscopic examination no changes in the animals were detected, which could be related to the treatment.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation study on rats over 6h the LC50 was above 200 ppm (equivalent to 5952 mg/m³).

Executive summary:

An acute inhalation study on rats over 6h with the test item was performed. The concentration of 200 ppm was sprayed into the air supply for 10 male Sprague-Dawley rats. After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).

Reference 3

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to Chaper 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Sex:

male

Dose descriptor:

discriminating conc.

Effect level:

200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Reference 4

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to Chapter 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

200 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: equivalent to 5952 mg/m³

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 952 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Updated Guideline adopted February 1987

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, D-W-4799 Borchen
- Weight at study initiation: 200 - 300 g
- Fasting period before study: no
- Housing: Singly in type III Makrolon cages
- Diet: ad libitum, Ssniff R 10 complete feed for rats, supplied by Ssniff Spezialfutter GmbH, D-W-4770 Soest
- Water: Drinking water ad libitum, supplied by Gelsenwasser, waterworks, D-W-4358 Haltern
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70%
- Photoperiod: Artificial light, 12-hour light/dark rhythm

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal skin
- Type of wrap: mull patch

REMOVAL OF TEST SUBSTANCE
- Washing: no

TEST MATERIAL
- Amount applied: 2.2 cm3/kg bodyweigh

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: after 1/2, 1, 2, 3, 4, 5 and 6 hours and once a day for the next two weeks
- Frequency of weighting: day 0, 7 and 14
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No signs of toxicity related to the test substance were found during the 14-day observation period. The animals showed no dermal reactions 24 hours after administration and up to the end of the observation period.

Gross pathology:

The necropsies at the end of the study revealed no macroscopic changes to organs, nor were there any abnormalities in the skin and subcutaneous tissue in the application area.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity test according to OECD 402 with male and female rats determined a LD50 > 2000 mg/kg bw.

Executive summary:

The test of the acute dermal toxicity of the test item for male and female rats with undiluted test substance in a limit test with a dose of 2000 mg/kg bodyweight according to OECD 402 was conducted. The volume administered was 2.2 cm3/kg bodyweight. Five male and five female animals showed normal bodyweight change during the 14-day observation period. No signs of toxicity related to the substance occurred either in the males or in the females. Necropsy at the end of the test showed no evidence of macroscopic changes to organs of any of the animals. The median lethal dose (LD5O) found in the limit test for acute dermal toxicity in rats was 2000 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to Chapter 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline study

Additional information

No data on the test item is available. With the read-across substances the following results were obtained:

In an acute oral toxicity study, conducted similar to OECD 401, groups of fasted white mice were given a single oral dose of the read across substance CAS 68583-51-7 at a dose of 5 mL/kg bw and observed for 14 days. No animals died during the study. No clinical signs were observed during the study period. The oral LD50 was determined to be > 5 mL/kg bw, which is correspondent to 4600 mg/kg bw.

An acute inhalation study on guinea pigs over 6h with the read across substance CAS 68583-51-7 was performed. The concentration of 200 ppm was prayed into the air supply for 12 guinea pigs (6 male, 6 female). After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).

An acute inhalation study on rats over 6h with the read across substance CAS 68583-51-7 was performed. The concentration of 200 ppm was sprayed into the air supply for 10 male Sprague-Dawley rats. After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).

The test of the acute dermal toxicity of the read across substance CAS 853947-59-8 for male and female rats with undiluted test substance in a limit test with a dose of 2000 mg/kg bodyweight according to OECD 402 was conducted. The volume administered was 2.2 cm3/kg bodyweight. Five male and five female animals showed normal bodyweight change during the 14-day observation period. No signs of toxicity related to the substance occurred either in the males or in the females. Necropsy at the end of the test showed no evidence of macroscopic changes to organs of any of the animals. The median lethal dose (LD5O) found in the limit test for acute dermal toxicity in rats was 2000 mg/kg bw.

Based on the results of the read across susbtances the test item is not acute toxic.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is classified and labelled as not acute toxic according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.