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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972
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

Constituent 1
Chemical structure
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:
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.
Body weight:
At study termination, body weights of males and females were comparable within the treatment groups.
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