Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters

Endpoint summary

Description of key information

Acute oral toxicity (OECD 401): LD50 > 2000 mg/kg bw

RA from source substance (CAS 130905-60-1)

Acute oral toxicity (similar to OECD 401): LD50 > 5000 mg/kg bw

RA from source substance (CAS 63705-03-3)

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:

weight of evidence

Study period:

17 September - 2 October 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

no analytical purity reported

GLP compliance:

yes (incl. QA statement)

Remarks:

Bezirksregierung, Lüneburg, Germany

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl.: (WI) BR - Wistar, white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Weight at study initiation: 268 – 293 g (males); 208 – 228 g (females)
- Fasting period before study: animals were fasted from 16 h before until 3 - 4 h after administration of the test article
- Housing: 5 animals of the same sex per cage in Macrolon cages type III
- Diet: Ssnif-R Alleindiät, pellets
- Water: drinking water supplied in drinking bottles, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 – 85 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined for clinical signs at the following time point after administration: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14. Individual body weights were determined weekly: on days 0 (before treatment), 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, grosspathology

Statistics:

LD 50 values were calculated according to Finney D. Y., Probit Analysis, 3rd edition, Cambridge, 1971

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of 14-day observation period

Gross pathology:

Necropsy examination revealed no substance-related findings

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Lack of data on test substance.

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

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
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: about 168 g (males) and 150 g (females)
- Fasting period before study: 16 h
- Housing: the animals were housed in groups of 5 in Makrolon 3 cages with a bedding of softwood granules.
- Diet: Altromin 1324, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 15 Mar 1988
To: 29 Mar 1988

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: there was a repeated observation of the animals on the application day. During the 14 d observation period, the animals were observed twice daily. Individual body weights were recorded the day prior to application, the day of application and on Days 2, 7 and 14 of the observation period.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14 d observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises two adequate and reliable studies (RL2) from reference substances with similar structure. Read-across is justified based on structural similarities and similar chemical behaviour. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

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 read-across

No data on acute toxicity after oral administration are available for the target substance Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters (CAS 92044-91-2). Therefore, read across from the relevant source substances Hexanedioic acid, mixed esters with decanoic acid, 12-hydroxyoctadecanoic acid, isostearic acid, octanoic acid, 3,3'-oxybis[1,2-propanediol] and stearic acid (CAS 130905-60-1) and 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) was applied to obtain information regarding acute toxicity after oral exposure.

Read-across from appropriate reference substances is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.5. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Acute oral toxicity

CAS 130905-60-1

An acute oral toxicity study was performed with the test substance according to OECD guideline 401 (Sasol, 1990). Groups of 5 male and 5 female rats received an oral gavage dose of 2000 mg/kg bw. The animals were observed for 14 days after administration. No mortality, clinical signs, abnormal body weight changes were observed. Necropsy examination revealed no substance-related findings. Thus, the acute oral LD50 was found to be greater than 2000 mg/kg bw.

CAS 63705-03-3

Another acute oral toxicity study was performed with the test substance similar to OECD guideline 401 (BASF, 1988). Groups of 5 male and 5 female rats received an oral gavage dose of 5000 mg/kg bw. The animals were observed for 14 days after administration. No mortality, clinical signs, abnormal body weight changes were observed. Necropsy examination revealed no substance-related findings. Thus, the acute oral LD50 was found to be greater than 5000 mg/kg bw.

              

The available data on acute toxicity following the oral route after application of the two analogue substances (CAS 130905-60-1 and CAS 63705-03-3) do not meet the criteria for classification according to Regulation (EC) 1272/2008.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.