Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral (read across, similar to OECD 401): LD50 female mouse ≥ 2000 mg/kg bw

Inhalation (read across, OECD 436): LC50 m/f rat: >5.7 mg/L air

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

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)
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:
female
Dose descriptor:
LD50
Remarks:
mouse
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 3687-46-5
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. Based on the available data, the target and the source substance are considered unlikely to differ in their acute toxicity potential. The acute oral LD50 > 2000 mg/kg bw for the source substance decyl oleate (CAS 3687-46-5) is expected to apply also for the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters ( no CAS).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable studies (Klimisch scores ≤ 2) from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile. 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

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 the Analogue Approach Justification document provided in Section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Remarks:
rat
Effect level:
> 5.7 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No mortality occurred. Apart from hunched position observed in all rats on day 2 after exposure, no further signs of adverse toxicity were observed during the 14-day observation period.
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. Based on the available data, the target and the source substance are considered unlikely to differ in their acute toxicity potential. The acute inhalation LC50 > 5.7 mg/L air (aerosol) for the source substance 2-ethylhexyl octadec-9-enoate (CAS 26399-02-0) is expected to apply also for the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable studies (Klimisch scores ≤ 2) from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile. 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 dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
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 3687-46-5

Acute dermal toxicity data from the source substance decyl octadec-9-enoate (CAS 3687 -46 -5) were selected as key results for reasons of structural similarity and data reliability. Additional supporting data from the source substance 2 -octyldodecyl isooctadecanoate (CAS 93803 -87 -3), for which an acute dermal LD50 of 2000 mg/kg bw for male and female rats was found, is available.

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. Based on the available data, the target and the source substance are considered unlikely to differ in their acute toxicity potential. The acute dermal LD50 was found to be > 2000 mg/kg bw for both analogue source substance, decyl oleate (CAS 3687-46-5) and 2 -octyldodecyl isooctadecanoate (CAS 93803-87-3). Therefore, an acute dermal LD50 > 2000 mg/kg bw was derived for the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable studies (Klimisch scores ≤ 2) from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile. 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.

Additional information

Justification for read-across

Data on the acute toxicity of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS) are not available. The assessment of acute toxicity 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 3687-46-5

In a non-guideline acute oral toxicity study, 5 female mice were administered 2000 mg/kg bw decyl oleate via the oral route (key study, 1994). The study report contained limited information on animal husbandry and no individual animal data. The summary indicated that no mortality occurred during the 6-day observation period, and that no clinical signs were noted in the animals. There were no effects on body weight. Therefore, the oral LD50 value for female mice is > 2000 mg/kg bw.

Acute inhalation toxicity

CAS 26399-02-0

The acute inhalation toxicity of 2-ethylhexyl oleate (CAS 26399-02-0) was assessed in a study performed according to OECD guideline 436 (key study, 2010). 3 rats/sex were exposed to 5.7 ± 0.4 mg/L air (actual concentration) of the test substance as an aerosol via nose-only route for 4 hours. The nominal concentration was 15.4 mg/L and the MMAD was 2.5-2.6 µm. No mortality occurred. The animals had a hunched posture on Day 2; no further clinical signs were observed during the 14-day observation period. The body weight gain was within the range that is normal for this strain and study type. No findings were reported during the macroscopic examination. The inhalation LC50 value is considered to be > 5.7 mg/L.

Acute dermal toxicity

CAS 3687-46-5

An acute dermal toxicity study (limit test) was performed with decyl oleate (CAS 3687-46-5) according to OECD guideline 402 (key study, 2010). 2000 mg/kg bw of the test substance was applied to the skin of 5 Wistar rats/sex under an occlusive dressing for 24 hours. No mortality occurred. Clinical signs were observed in all males on Day 1 and/or 2; as piloerection (2/5 males) or chromodacryorrhoea (3/5 males). No clinical signs were noted in females. The body weight increases were within the range expected for rats used in this type of study and no treatment-related findings were reported during the necropsy and histopathological examination. Erythema (grade 1) was observed on the treated skin for up to 4 days during Day 3-7 in 4/5 females. Scales or scabs (grade 1) were noted on the treated skin area in 5/5 females and 3/5 males for up to 9 days during Day 7-15 of the observation period. The dermal LD50 value is considered to be > 2000 mg/kg bw.

CAS 93803-87-3

The dermal effects of 2-octyldodecyl isooctadecanoate were investigated in an acute dermal toxicity GLP study performed similar to OECD guideline 402 (supporting study, 1998). In a limit test 2000 mg/kg bw of the undiluted test substance was applied to the shaved skin of 5 rats/sex for 24 hours under occlusive conditions. After the exposure period, residual test substance was removed and the animals were observed for a period of 14 days. No mortality occurred. Red staining of the fur was observed in 1/5 females on Day 8 – 13. As this is a known sign of stress in rats, it was not considered to be a toxicologically relevant effect. Male and female rats showed the expected gain in body weight throughout the study. The necropsy and histopathological examination did not reveal any substance-related findings. Based on these results, the dermal LD50 value for male and female rats is > 2000 mg/kg bw.

Overall conclusion for acute toxicity

The reliable data available for the read-across analogue substances indicate a very low level of acute toxicity following the oral, inhalation and dermal route, as LD50 and LC50 values were greater than the administered limit values. Therefore, as the available data did not identify any acute toxicity, Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS) is not considered to be hazardous following acute exposure via the oral, inhalation 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, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS), 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 oral, inhalation and dermal toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.