Registration Dossier

Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 15000 mg/kg bw

RA from source substance Ditridecyl adipate (CAS 16958 -92 -2)

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
/ Basic data given. Report was limited, study was not GLP conform and purity of test substance was not given.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 18 h
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
15000 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: daily
- Necropsy of survivors performed: no data
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
On the day of application all animals showed diarrhea. Over the course of the study numbers of animals with diarrhea declined (1 male and female on day 1, and two males each on day 2 to day 4). Thereafter, no diarrhea was observed until day 13 and day 14 when 1 male each showed diarrhea. Other symptoms were lethargy from day 0 to day 2 shown by 2 males and females each, 1 male and female each and 1 male, respectively. Additionally, on day 0 one male animal appeared flaccid. From day 2 to day 4 all animals had an oily body, on day 2 and day 3 one male showed ptosis and on day 12 and 13 one male animal had chromorhinorrhea and on day 14 two male animals.

Table 1: Overview of clinical symptoms observed in rats treated by single oral gavage with 15000 mg/kg bw of test item

number of rats with sign (male/female)

 day 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
diarrhea 5/5 1/1 2/0 2/0 2/0                 1/0 1/0
lethargy 2/2 1/1 1/0                        
flaccid 1/0                            
body oily     5/5 5/5 5/5                    
ptosis     1/0 1/0                      
chromorhinorrhea                         1/0 1/0 2/0
Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate, reliable (Klimisch score 2) study from a reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details).
The information from this source provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information is 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

Acute toxicity

Justification for read-across

There are no data for acute toxicity available for Fatty acids, C18 -unsaturated, 1,6 Hexanediol Diester. To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.5, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.

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 substances 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).

As no experimental/measured data are available on acute toxicity of Fatty acids, C18 -unsaturated, 1,6 Hexanediol Diester following the oral route, read-across to reliable data on the analogue substance Ditridecyl adipate (CAS 16958-92-2) was conducted.

Acute oral toxicity

CAS 16958-92-2

The acute oral toxicity of the test substance was assessed in a study according to OECD 401 (Moreno, 1978). 5 female and 5 male rats received a dose of 15000 mg/kg bw via oral gavage. No mortality occured. Clinical signs were observed in all animals mainly in form of diarrhea. The number of animals affected declined during the observation time. Other symptoms were lethargy, flabbiness, oily body, ptosis and chromorhinorrhea, which were reversible, except of the chromorhinorrhea, which was observed on the last day of observation (no information given on whether it persisted or not).

Therefore, the LD50 value was selected to be exceeding 15000 mg/kg bw in this study.

Reliable data available for the read-across analogue substance indicate no acute toxicity following the oral route as the defined LD50 value exceeds the limit value and no adverse effects at the applied dose have been observed. Thus,

Fatty acids, C18 -unsaturated, 1,6 Hexanediol Diester

is not considered as hazardous after acute exposure.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.