Fatty acids, C16-18, esters with diethylene glycol

Endpoint summary

Description of key information

Oral: LD50 > 2000 mg/kg bw 

Inhalation (read-across): LC50 > 4.3 mg/L (time-extrapolated value, corresponding to 2.916 mg/L after 6 h exposure)

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Basic data given (no details on test substance given, only limited data on results available)

Principles of method if other than guideline:

Acute toxicity was tested in male mice after receiving a single dose of the test item. The animals were observed over a time period of 6 days.

GLP compliance:

not specified

Test type:

other: no guideline followed

Species:

mouse

Strain:

other: NMRI EOPS

Sex:

male

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 6 days

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed until the end of the observation eriod.

Clinical signs:

other: No signs indicative for anomalies observed until the end of the observation period.

Body weight:

other body weight observations

Remarks:

body weight appeared normal.

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

> 4.3 mg/L air

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2) and consistent studies, from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s) and common precursors/breakdown products (refer to endpoint discussion for further details).
The selected studies are 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 dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Acute toxicity following oral exposure

Acute toxicity via the oral route of Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) has been investigated in NMRI EOPS mice (EViC-CEBA, 1994). The results of the conducted study were reported in a summary with limited information. However, as basic data are provided sufficient for hazard assessment, the study was considered as reliable (reliability 2). 3 male mice were treated with a single dose of 2000 mg/kg bw test substance. Animals were observed for 6 days and no clinical signs or mortalities were observed. Body weight evolution revealed no abnormal findings. Based on the results of the conducted study, a LD50 > 2000 mg/kg bw was defined for Fatty acids, C16-18, esters with diethylene glycol. The available study is considered sufficient for the evaluation of acute toxicity although the observation period was shorter compared to the current OECD guidelines valid for acute toxicity following oral ingestion, as no signs indicative for serious clinical toxicity were observed up to the end of the observation period, and hence, mortality is not expected to occur at later time points.

One product of hydrolysis, diethylene glycol (DEG, CAS 111-46-6), exhibits low acute toxicity and is classified as Acute Tox. 4, H202 (Annex VI, Regulation (EC) 1272/2008). However, as the test substance was tested up to the currently applied limit dose for classification, Fatty acids, C16-18, esters with diethylene glycol is not considered to meet the classification criteria for acute toxicity according to EC Regulation 1272/2008.

 

Acute toxicity following inhalation

CAS 68583-51-7

The acute inhalation toxicity of Decanoic acid, mixed diesters with octanoic acid and propylene glycol was evaluated in two studies similar to OECD guideline 403 in a limit test (Food and Drug Research Laboratories, 1978 a,b). A group of 10 male Sprague-Dawley rats and a group of 10 male and female guinea pigs and 3 control animals, respectively, were exposed whole body to a generated aerosol of 200 ppm (equivalent to 2.916 mg/L air) for 6 h. The animals were observed for a period of 7 days following administration. No mortality occurred and no clinical signs of toxicity were apparent during the study period in any animal. Necropsy revealed no substance-related findings in both studies. Therefore, the LC50 for male rats and male and female guinea pigs was greater than 200 ppm (2.916 mg/L).

Regarding the fact that the animals were exposed to 200 ppm (2.916 mg/L) for 6 h compared to the required exposure time of 4 h according to Regulation (EC)1272/2008, the lack of clinical signs and mortality until the end of the observation period, and the lack of systemic toxicity in acute and repeated dose studies following oral ingestion, the available data are considered to conclusive but not sufficient for classification.

As the classification criteria for acute inhalation toxicity relate to a 4-h experimental exposure, extrapolation of the results to 4 h is considered appropriate using Haber’s Law (C.t = k) according to Regulation (EC) 1272/2008 and Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance (ECHA, 2015). Using this approach, a time-extrapolated LC50 value of 4.3 mg/L is achieved (2.916 [mg/L] x 6 h = c [mg/L] x 4h).

As the extrapolated LC50 value is close to the defined cut off value of 5 mg/L, and no hazardous properties were identified in all available acute, short and longterm studies, the available data are considered as conclusive but not sufficient for classification in regard to acute inhalation toxicity. Moreover, based on the physical state and the physico-chemical properties of Fatty acids, C16-18, esters with diethylene glycol, absorption following inhalation is expected as negligible.

Acute dermal toxicity

Testing by the dermal route is not considered appropriate in accordance with Annex VIII, Section 8.5.3, and the amendment proposed by CARACAL as the target substance Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) did not cause mortality or adverse clinical signs in an acute toxicity study following oral administration of up to 2000 mg/kg bw in mice (Dufour, 1994). Furthermore, no systemic effects were noted in the in vivo skin irritation and skin sensitisation studies performed either with the target substance Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) (Dufour, 1994) or the analogue substance Ethylenglycol distearate (CAS 627-83-8) (Müller, 1982). Hence, no additional knowledge is expected to be gained by an acute dermal toxicity study considering the outcome of the available, relevant studies (including acute oral toxicity and in vivo studies with dermal exposure).

Overall conclusion on acute toxicity

Based on the available data, the test substance is not considered to exhibit hazardous properties after single oral and dermal contact and following inhalation.

Justification for classification or non-classification

Based on test substance-specific data and on analogue read-across approach, the available data on acute oral and inhalation toxicity do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification. No data on acute dermal toxicity are available.