Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral (OECD 425, RL1): LD50 > 5000 mg/kg bw (read-across)

 

Acute toxicity, inhalation (OECD 403, RL1): LC50 > 5.1 mg/L air (read-across)

 

Acute toxicity, dermal (OECD 402): LD50 > 2000 mg/kg bw (read-across)

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:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 95912-89-3

The available acute oral toxicity study with CAS 95912-89-3 was selected as the key study for reasons of structural similartiy to the registered substance and data reliability.

Additional acute oral toxicity studies from the source substances CAS 11138-60-6 and CAS 146289-36-3 were taken into account for supporting information. For all source substances the acute oral LD50 values were 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 LD50 value for acute oral toxicity has been determined to be > 2000 mg/kg bw using adequate analogue source substances. 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. Therefore, the target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to be hazardous following acute exposure via the oral route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 1) and consistent studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in physico-chemical/ecotoxicological/toxicological properties (refer to endpoint discussion for further details). The selected studies are thus 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

Link to relevant study records
Reference
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:
refer to analogue justification provided in IUCLID section 13
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.05 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Source: CAS 95912-89-3
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
The LC50 value for acute inhalation toxicity has been determined to be > 5.05 mg/L air using an adequate source substance CAS 95912-89-3. 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. Therefore, the target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to be hazardous following acute exposure via the inhalation route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate, reliable (Klimisch score 1) and consistent study, from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in physico-chemical/ecotoxicological/toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII-VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

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:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 11138-60-6
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The LD50 value for acute dermal toxicity has been determined to be > 2000 mg/kg bw using an adequate source substance CAS 11138-60-6. 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. Therefore, the target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to be hazardous following acute exposure via the dermal route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate, reliable (Klimisch score 1) and consistent study, from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in physico-chemical/ecotoxicological/toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII-VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

Additional information

Justification for read-across

Experimental data on acute oral, dermal and inhalation toxicity of Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid are not available. The assessment was therefore based on studies conducted with analogue source substances as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint, the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. 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 95912-89-3

An acute oral toxicity study was performed with Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) under conditions of GLP and according to the up-and-down method described in OECD 425 (Key, 2010). In this experiment, 3 female Sprague Dawley rats were treated with the test substance via gavage at a limit dose of 5000 mg/kg bw. In none of the sequentially tested animals, mortalities and clinical signs of toxicity were observed up to the end of the 14-day observation period. No effect on body weight was noted. Macroscopic and microscopic examinations did not reveal any treatment-related findings. Hence, an oral LD50 of > 5000 mg/kg bw was derived for Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane.

CAS 11138-60-6

A reliable acute oral toxicity study was conducted with Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) according to OECD 401 as a limit test (Supporting, 1990). Upon treatment of male and female rats with 2000 mg/kg bw of the test substance no mortality or enduring adverse effect was observed during the 14 d observation period. The animals had normal weight gain until the end of the observation period. The LD50 value was, therefore, determined to be > 2000 mg/kg bw.

CAS 146289-36-3

An acute oral toxicity study with Isononanoic acid, mixed esters with 2-methylbutanoic acid, 3-methylbutanoic acid, pentaerythritol and valeric acid (CAS 146289-36-3) was conducted according to OECD 401 and under GLP conditions as a limit test (Supporting, 1991). No mortality occurred during the study period. No clinical signs of toxicity were observed up to the end of the 14-day observation period. No effect on body weight was noted and necropsy revealed no substance-related findings. Therefore, the LD 50 was determined to be > 2000 mg/kg bw.

Acute dermal toxicity

CAS 11138-60-6

An acute dermal toxicity (limit test) was performed on Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) according to OECD 402 and GLP (Key, 1997). 5 male and female New Zealand White rabbits were exposed to 2000 mg test substance /kg bw for 24 hours on the back skin under semiocclusive conditions. The observation period was 14 days. No mortality or clinical signs of systemic toxicity were noted in any animal during the study period. 4 male animals lost 0.1 kg body weight whereas the remaining animals had a constant body weight over the study period. Necropsy at study termination revealed no abnormalities. Thus, the acute dermal LD50 in rabbits for Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol was found to exceed 2000 mg/kg bw.

Acute inhalation toxicity

CAS 95912-89-3

In a GLP-conform study according to OECD 403, the acute inhalation toxicity of Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) was investigated in Crl:CD(SD) rats (Key, 2012). Five male and five female animals were exposed to the test aerosol at an analytical atmosphere concentration of 5.05 mg/L air (5050 mg/m³ air) for four h using a nose-only exposure system. No mortality occurred during the 14-day observation period. Clinical signs of toxicity included slight ataxia, slight tremor and slight dyspnoea immediately until 30 min or 3 h after the end of exposure in all male and female animals. Body weights were not adversely affected by treatment and the expected weight gain was observed in all animals during the course of the study. At necropsy, no pathological findings were observed. Based on these results, the LC50 value for Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane was considered to be > 5.05 mg/L air.

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, C8-10-(even numbered), esters with pentaerythritol and adipic acid 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 dermal, 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.