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Administrative data

Description of key information

Oral, mouse and rat: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
29 Aug - 21 Sep 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The analytical purity of the test substance was not reported.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
yes
Remarks:
analytical purity of the test substance was not reported
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: OFA.Sprague-Dawley (IOPS Caw)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, L'Arbresle, France
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 145.0 g (mean, females) and 164.4 g (mean, males)
- Fasting period before study: 18 h
- Housing: animals were caged in groups of 5/sex in type FI polycarbonate cages (365 mm x 225 mm x 180 mm). Bedding was changed weekly.
- Diet: complete pelleted rat-mouse maintenance diet U.A.R. formule A.04 CR, U.A.R. (Epinay-S/Orge, France), ad libitum
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 35 mL/kg bw
Doses:
29.75 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations of mortality and signs of toxicity were made 15 minutes and 1, 2 and 4 hours after administration, and daily thereafter; animals were weighed on Day -1, Day 1 prior to dosing and on Day 8 and 15.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 29 750 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-day observation period.
Gross pathology:
No substance-related findings were noted during the necropsy and histopathological examination.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
08 - 13 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Data on analytical purity, guideline and animal husbandry are missing.
Principles of method if other than guideline:
The LD50 of the test substance was determined by administering 5 female mice 2000 mg/kg bw orally. The animals were observed for mortality and signs of toxicity for 6 days, and the body weight was determined at the start and end of the study period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-21 g
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Necropsy of survivors performed: no
- Other examinations performed: mortality, clinical signs, body weight
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period.
Clinical signs:
other: No signs of toxicity were observed during the study period.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
27 May - 09 Jun 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The analytical purity of the test substance was not specified; necropsy was not performed.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
necropsy not performed
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
necropsy not performed
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 220.7 - 243.6 g (males) and 199.0 - 216.0 g (females)
- Fasting period before study: animals were fasted for 24 hours prior to dosing
- Housing: animals were housed 5 per cage in polycarbonate cages (450mm x 300mm x 200mm), which had a type E wire floor and contained absorbent material
- Diet: feed A04 (U.A.R., Epinay Sur Orge, France), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-75
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 May 1999 To: 9 Jun 1999
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
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: 14 days
- Frequency of observations and weighing: animals were observed for mortality and clinical signs immediately, 15 mins and 6 hours after administration, and daily thereafter (5 days per week); animals were weighed on Day 0, 7 and 14
- Necropsy of survivors performed: no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality or clinical signs were observed at this dose level.
Mortality:
There was no mortality during the study period.
Clinical signs:
other: No clinical signs were observed during the 14-day study period.
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
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2) and consistent studies 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 (refer to the endpoint discussion for further details).
The selected study is 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

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Analogue justification

No data on the acute oral toxicity of Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) are available.The assessment of acute toxicity was therefore based on studies conducted with 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 22766-83-2

In an acute oral toxicity study performed according to OECD guideline 401 and in compliance with GLP, 29.75 g 2-octyldodecyl myristate/kg bw was administered via gavage to 5 OFA.Sprague-Dawley (IOPS Caw) rats/sex (WoE, 1989). No mortality occurred during the 14-day observation period. No clinical signs were observed in the animals during the study period. The increase in body weight was within the normal range reported for animals of this strain. Gross pathology did not reveal any substance-related findings in the treated animals. Therefore, the oral LD50 value for male and female rats is > 29.75 g/kg bw.

CAS 3687-46-5

In a reliable non-guideline study, 5 female mice were administered 2000 mg/kg bw Decyl oleate (CAS 3687-46-5) via gavage (WoE, 1994). The study report contained limited information. No mortality occurred and no clinical signs were recorded during the 6-day observation period. There were no effects on body weight. The oral LD50 value is considered to be > 2000 mg/kg bw.

CAS 72576-80-8

The potential for acute oral toxicity of Hexadecanoic acid, -isooctadecyl ester (CAS 72575-80-8) was assessed in a study performed according to OECD guideline 401 (WoE, 1999). 5 rats/sex were administered 2000 mg/kg bw of the test substance by gavage. No mortality occurred. No clinical signs were observed during the 14-day observation period and the body weights were comparable between the control group and treatment group. A gross pathology examination was not performed. Based on the results of the conducted study, the oral LD50 value is considered to be > 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 route, as LD50 values were greater than the currently applied limit value. Therefore, as the available data did not identify any hazard for acute toxicity, Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) is not expected to be hazardous following acute oral exposure.

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, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6), data will be generated from information on 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 read-across approach, the available data of Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.