Diisooctyl adipate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No details on test animals and experimental conditions; observation period only 7 days.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Reference 2

Reference Type:

secondary source

Title:

ECB IUCLID set dihexyl adipate

Author:

ECB

Year:

2000

Bibliographic source:

EUROPEAN COMMISION – European Chemicals Bureau

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no details on test animals and experimental conditions; observation period only 7 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dihexyl adipate

EC Number:

203-757-7

EC Name:

Dihexyl adipate

Cas Number:

110-33-8

Molecular formula:

C18H34O4

IUPAC Name:

dihexyl adipate

Details on test material:

- Name of test material (as cited in study report): Di-m-Hexyl adipate
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

10000, 12600 and 15800 mg/kg bw

No. of animals per sex per dose:

5 animals per dose (10000 and 15800 mg/kg bw: 2 males and 3 females; 12600 mg/kg bw: 3 males and 2 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 800 mg/kg bw

Based on:

test mat.

Mortality:

1 female rat of the 12600 mg/kg bw group as well as 1 male and 1 female rat or the 15800 mg/kg bw group died during day 1 and 3. No mortalities were observed at 10000 mg/kg bw/day.

Clinical signs:

other: Clinical signs of toxicity in survivors included reduced appetite and reduced activity 2 to 3 days after application of the test substance. Furthermore, increasing weakness and collapse were observed.

Gross pathology:

At autopsy, haemorrhage of the lung, decolouration of the liver and acute gastrointestinal inflammation was observed. In surviving animals, no abnormal findings were observed in viscera at macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified