Diisodecyl sebacate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions, performed on a read-across compound

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

3 animals used per sex per group (5 recommended), animals observed for 7 days (14 recommended), insufficient detail to further judge compliance with guideline

GLP compliance:

no

Remarks:

predates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diisodecyl adipate

EC Number:

248-299-9

EC Name:

Diisodecyl adipate

Cas Number:

27178-16-1

Molecular formula:

C26H50O4

IUPAC Name:

bis(8-methylnonyl) adipate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): di-isodecyl adipate
- Molecular formula (if other than submission substance): C26H50O4
- Molecular weight (if other than submission substance): 426.677
- Smiles notation (if other than submission substance): C(CCCCC(OCCCCCCCC(C)C)=O)(OCCCCCCCC(C)C)=O
- InChl (if other than submission substance): InChI=1S/C26H50O4/c1-23(2)17-11-7-5-9-15-21-29-25(27)19-13-14-20-26(28)30-22-16-10-6-8-12-18-24(3)4/h23-24H,5-22H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: no data
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

other: Alderley Park SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Alderley Park
- Age at study initiation: no data
- Weight at study initiation: 160 to 260 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

2500, 5000 or 10,000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology (at least on kidney)

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths were seen within seven days of treatment

Mortality:

No animals died within seven days of treatment.

Clinical signs:

other: Animals given 5000 or 10,000 mg/kg bw were incontinent for four days after dosing.

Gross pathology:

The kidneys of all treated animals were reticulated at autopsy (seven days after dosing), but were microscopically normal.

Other findings:

- Organ weights: no data
- Histopathology: small chronic inflammatory foci and mild stress changes were seen in the thymus. Gastric irritation and non-specific stress changes were seen in a further group of 3 males given 10,000 mg/kg bw and killed 24 hours later. [These changes may have been macroscopic.]
- Potential target organs: no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a study similar to that described by OECD Guideline 401, no deaths were seen in rats following a single gavage administration of DIDA at up to 10,000 mg/kg bw.

Executive summary:

The acute oral toxicity of diisodecyl adipate (DIDA) has been investigated in Alderley Park SPF rats, in a study similar to that described by OECD Guideline 401.

Groups of rats (3/sex) were given a single gavage treatment with undiluted DIDA at 2500, 5000 or 10,000 mg/kg bw. Rats were observed for clinical signs of toxicity until autopsy seven days after treatment. An additional group of rats was given 10,000 mg/kg bw and killed after 24 hours.

No deaths were observed before scheduled necropsy. The LD50 was therefore determined to be more than 10,000 mg/kg bw. According to the EU guidelines, DIDA does not require classification as acutely toxic via the oral route.