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Description of key information

Oral (similar to OECD 401): LD50 > 5000 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:
experimental study
Adequacy of study:
key study
Study period:
11 Jun - 20 Aug 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Limited report details, no test substance purity reported
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Liquid
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: mean BW on the day of application, prior to application: 176 g in males, 160 g in females
- Fasting period before study: fasted for 16 h prior application and 3 h after application
- Housing: Makrolon 3 cages with soft wood granulate
- Diet: Altromin Haltungsdiät 1324, Altromin, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): approx. 45-60
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
Oleum Arachidis DAB 7 (Lamotte, Bremen, Germany)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (g/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
5000 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 clinical observations: several times on the day of application, and thereafter twice daily throughout the 14 days of observation
- Frequency of mortality recording: 1, 2, 7, and 14 days after application
- Frequency of weighing: prior to and 2, 7, 14 days after application
- Necropsy of survivors performed: yes, after euthanasia using ether
Statistics:
Not required
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the observation period.
Clinical signs:
Reduced activity and piloerection was observed in all 10 animals for 3-8 hours after application.
Body weight:
Mean body weights increased in males as well as in females.
Gross pathology:
No abnormal findings.
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 an adequate, reliable (Klimisch score 2) and consistent study. 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

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Exposure to workers: Inhalation exposure to workers in formulation/manufacturing processes would be possible, as it is a liquid substance; however only closed process systems are used. Therefore no exposure to workers is expected.
For professional/consumer exposure: inhalation exposure is unlikely or negligible as the substance is in a preparation, therefore exposure via inhalation is unlikely taking into account the low vapour pressure and/the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Regulation (EC) No 1907/2006, Annex VIII, section 8.5, column 2, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route in addition to the oral route (8.5.1) for substances other than gases. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.
In consideration of the same section (Column 2 of Annex VIII, Section 8.5.3), testing by the dermal route does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route, and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).
The target substance Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) did not cause mortality or adverse clinical signs in an acute toxicity study following oral administration of 5000 mg/kg bw in male and female Wistar rats. Furthermore, no systemic effects were noted in vivo skin irritation and skin sensitisation studies performed with the analogue substances Fatty acids, C16-18, isotridecyl esters (CAS 95912-88-2), Decyl oleate (CAS 3687-46-5), 2-ethylhexyl oleate (CAS 26399-02-0), 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), and Fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0).
Workers are not exposed due to a closed process system. Professionals/consumers exposure is expected to be very low due to the concentration of <2% in the preparation and absence of acute oral toxicity. Acute dermal toxicity is not considered relevant since the concentration of the target substance in the preparation is <2% throughout the supply chain.
Therefore, testing acute dermal toxicity should be avoided for reasons of animal welfare, especially as the substance is not classified as STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.


Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

The acute oral toxicity of Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) was assessed in a GLP study comparable to OECD guideline 401 (key study, 1985). Administration of 5000 mg/kg bw to 5 rats per sex via oral gavage did not cause mortality. Reduced activity and piloerection in all 10 animals was observed for 3-8 hours after application. No other abnormalities were recorded during the 14-day observation period. There were no effects on body weight. The acute oral LD50 value in rats was found to be > 5000 mg/kg bw.

Overall conclusion for acute toxicity

The reliable data available for the target substance indicate a very low level of acute toxicity following exposure via the oral route, as the LD50 value were greater than the administered limit values. Therefore, as the available data did not identify any acute toxicity, Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) is not considered to be hazardous following acute exposure.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.