Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral (read-across, OECD 401): LD50 m/f rat > 2000 mg/kg bw

Dermal (read-across, equivalent to OECD 402): LD50 m/f rat > 2000 mg/kg bw

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:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
key study
Justification for type of information:
Refer to analogue justification provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 151661-88-0

The acute oral toxicity study with the analogue source substance Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol (CAS 151661-88-0) was selected as key result for reasons of structural similarity and data reliability. Supporting in vivo data on acute oral toxicity is given for the source substances Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) and Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8). For all source substances the acute oral LD50 value in rats or mice was found to be >2000 mg/kg bw.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their acute toxicity potential. The acute oral LD50 in rats and mice was found to be > 2000 mg/kg bw for the source substances Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol (CAS 151661-88-0), Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) and Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8). Therefore, an acute oral LD50 value of >2000 mg/kg bw is considered for the hazard assessment and C&L purposes for the target substance Fatty acids, tall-oil, esters with ethylene glycol (68187-85-9).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable studies (Klimisch score 2). The selected studies are sufficient to fulfil the standard information requirements set out in Annex VII, 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

Link to relevant study records
Reference
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:
Refer to analogue justification provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 151661-88-0
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The read across approach is justified in the analogue justification. The target and source substance are considered unlikely to differ in their acute toxicity potential. The acute dermal LD50 value was found to be >2000 mg/kg bw for the source substance Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol (CAS 151661-88-0). Therefore, an acute dermal LD50 value of >2000 mg/kg bw was considered for the hazard assessment and C&L purposes for the target substance Fatty acids, tall-oil, esters with ethylene glycol (68187-85-9).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2). The selected studies are sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

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 oral toxicity

CAS 151661-88-0

The acute oral toxicity of Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol (CAS 151661-88-0) was assessed in a GLP study conducted according to OECD guideline 401 (key study, 1989). Administration of 2000 mg/kg bw to 5 rats per sex via oral gavage did not cause mortality and no toxicologically relevant clinical signs were observed during the 14-day study period. There were no significant effects on body weight and no treatment-related pathological findings. The acute oral LD50 value in male and female rats was found to be > 2000 mg/kg bw.

CAS 91031-31-1

The acute oral toxicity of Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) was assessed in a study conducted equivalent to OECD guideline 401 (supporting study, 1982). Administration of 2000 mg/kg bw to 5 rats per sex via oral gavage did not cause mortality and no toxicologically relevant clinical signs were observed during the 14-day study period. There were no significant effects on body weight and no treatment-related pathological findings. The acute oral LD50 value in male and female rats was found to be > 2000 mg/kg bw.

CAS 85116-97-8

The acute oral toxicity of Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) was assessed in a study conducted similar to OECD guideline 401 (supporting study, 1994). Administration of 2000 mg/kg bw to 5 male mice via the oral route did not cause mortality and no toxicologically relevant clinical signs were observed during the 6-day observation period. There were no significant effects on body weight. The acute oral LD50 value in male mice was found to be > 2000 mg/kg bw.

Acute dermal toxicity

CAS 151661-88-0

An acute dermal toxicity GLP study was performed with Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol (CAS 151661-88-0) equivalent to OECD guideline 402 (key study, 1989). 2000 mg/kg bw of the test substance was applied to the skin of 5 rats/sex under an occlusive dressing for 24 h. No mortality occurred and no treatment-related clinical signs were observed during the 14-day observation period. No signs of skin irritation were found. Body weights were within the expected range for this species and strain. The LD50 value in male and female rats was > 2000 mg/kg bw.

Overall conclusion for acute toxicity

The reliable data available for the source substances indicate a very low level of acute toxicity via the oral and dermal route, as LD50 values were greater than the administered limit values. Therefore, as the available data did not identify any acute toxicity, Fatty acids, tall-oil, esters with ethylene glycol (CAS 68187-85-9) is not expected to be hazardous following acute exposure via the oral and dermal route.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, tall-oil, esters with ethylene glycol (CAS 68187-85-9) data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.