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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no determination of body weights, limited reporting)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; no determination of body weights, limited reporting
Principles of method if other than guideline:
No guideline stated in report, but method used is similar to OECD TG 401
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): diisotridecyl adipate

Test animals

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: approx. 18 h

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
15.0 g/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: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit test, 15000 mg/kg bw is the only dose tested
Mortality:
no mortalities were obserded (0/10 animals)
Clinical signs:
Diarrhea (from day 0 to day 4 with reducing number of animals)
Lethargy (from day 1 to day 2 in few animals)
Body oily (from day 2 to day 5 in all animals)
Chromorhinorrhea (from day 12 to day 14 in 1 to 2 male animals)
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity test (only 1 dose, limit test), diisotridecyl adipate did not cause any mortality at a dose of 15000 mg/kg bw. Diisotridecyl adipate is not to be classified according to EU regulations.
Executive summary:

The acute oral toxicity of diisotridecyl adipate was determined in 5 male and 5 female Wistar rats each receiving 15 g/kg bw of the test material by oral gavage (limit test). The observation period was 14 days.

 

None of the animals died. Clinical signs (diarrhea, lethargy, oily bodies) were observed predominantly during day 0 to 5. Information on gross pathology is not reported.

 

The acute oral LD50 was determined to be > 15000 mg/kg bw in rats (Moreno/Mobil, 1978a).

 

This study is considered acceptable. It follows the principles of the retracted OECD test guideline 401 (Acute Oral Toxicity). Deviations are no determinatin of body weights and limited reporting.