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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 (abdominal area as test site, for half of the animals abrasion of skin prior to test substance application, occlusive wrapping, 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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
; abdominal area as test site, for half of the animals abrasion of skin prior to test substance application, occlusive wrapping, limited reporting
Principles of method if other than guideline:
No guideline stated in report, but method used is similar to OECD TG 402
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:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: abdominal area; size not reported
- % coverage: no data
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rabbits skin was cleansed
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (sex not specified)
Control animals:
not required
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:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit test, 5000 mg/kg bw is the only dose tested
Mortality:
no mortalities were observed (0/10 animals)
Clinical signs:
Diarrhea (4 animals, various days between day 4 and 14)
Emaciation (2 animals, days 6 through 14)
Lethargy (1 animal, days 9 through 14)
Abdomen bloated (1 animal, days 13 and 14)
Body weight:
Five animals showed reduced body weights (0.1 to 0.2 g) at the end of the study. For one animal, the body weight was the same. In four animals, body weights had increased by 0.1 or 0.2 g.
Gross pathology:
no data
Other findings:
- Other observations: at the end of exposure, erythema scores were 1 or 2 for 9 animals. One animals showed a score of 0. Edema was noted in 3 animals (score 1 or 2).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity test (only 1 dose, limit test), diisotridecyl adipate did not cause any mortality at a dose of 5000 mg/kg bw. Diisotridecyl adipate is not to be classified according to EU regulations.
Executive summary:

The acute dermal toxicity of diisotridecyl adipate was determined in 10 New Zealand White rabbits each receiving a single dose of 5000 mg/kg bw of test substance (limit test). The exposure time was 24 hours followed by an observation period of 14 days. Before application of test substance, the clipped skin of half of the test animals was abraded. At the end of the exposure period, the skin was cleansed.

 

No mortality was observed during the test. Two animals showed signs of emaciation. Other clinical observations were diarrhea (4 animals), and in single animals lethargy and bloated abdomen. Body weight development was below normal.

 

The acute dermal LD50 was determined to be > 5000 mg/kg bw in rats (Moreno/Mobil 1978b).

 

Overall, the study was conducted similar to OECD test guideline 402 with some restrictions (abdominal area as test site, abrasion of skin prior to test substance application, occlusive wrapping, limited reporting).