Diisodecyl azelate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, although only short summary of the study.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

; only 14 days of administration, no clinical chemistry, ophthalmoscopy or neurology analyses performed. Lack of detailed reporting, lack of details on test substance, only 7 animals tested

GLP compliance:

no

Limit test:

yes

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 (C24H46O4-C28H54O4)

IUPAC Name:

bis(8-methylnonyl) adipate

Details on test material:

- Name of test material (as cited in study report): Di-isodecyl adipate
- Analytical purity: no data

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 130-160 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

14 days

Frequency of treatment:

once daily

Doses / concentrations

Remarks:

Doses / Concentrations:
1000 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

7

Control animals:

yes

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: daily

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: Animals were bled 24 hours after the last dose.
- How many animals: all
- Parameters checked: Hb, PCV, MCHC, MCD, Reticulocytes, Differential White Blood cells, Platelets, Kaolin-Cephalin, Prothrombin

CLINICAL CHEMISTRY: No

URINALYSIS: Yes
- Time schedule for examinations: The final 24-hour urine was tested for bilirubine, glucose, protein and pH.

NEUROBEHAVIOURAL EXAMINATION: No

OTHER: liver weights were measured

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
2 male and 2 female animals were killed for histological examination 24 hours after the last dose and the remainder were killed seven days later.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

not examined

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not examined

Details on results:

There were no toxic signs during the experiment and liver weights and body weight gains were comparable with controls.
Haematological examination of the rats showed no changes. No changes were found in the urine.
At autopsy there were no abnormalities detected either macroscopically or microscopically.

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: clinical signs; mortality; body weight; haematology; urinalysis; gross pathology; organ weights; histopathology;

Target system / organ toxicity

Critical effects observed:

not specified