Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
guideline study with acceptable restrictions
Remarks:
Basic data given. The test was performed on intact and abraded skin. Test substance purity not given.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
secondary source
Title:
Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
Author:
US-EPA (American Chemistry Council's Aliphatic Esters Panel)
Year:
2010
Bibliographic source:
High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act Regulations (16 CFR 1500.40)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(tridecyl) adipate
EC Number:
241-029-0
EC Name:
Bis(tridecyl) adipate
Cas Number:
16958-92-2
Molecular formula:
C32H62O4
IUPAC Name:
ditridecyl adipate

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2 kg (mean)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: abdomen, not further specified

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rabbits were 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:
5 intakt skin (uneven numbered animals)
5 abraded skin (even numbered animals)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing carried out on day 0 and 14, Draize scores determined on day 1, observation for clinical signs daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, skin reactions

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Animals with intakt skin: Diarrhoea was seen for animal 1 at days 9 and 10 and for animals 3 at days 4 to 8. Animal 5 had a bloated abdomen on day 13 and 14.
Animals with abraded skin: Diarrhoea was seen for animal 2 at day 5 and for animal 4 on days 5 to 14. On day 8 to day 10 animal 2 seemed to be slightly emaciated while animal 4 was emaciated on days 6 to 14. Animal 4 was also lethargic on days 10, 12, 13 and 14

Body weight:
Over the whole study period mean body weight over all animals did not change.
Gross pathology:
no data
Other findings:
- Other observations:
Erythema (grade 1 or 2) was found in 9/10 animals, whereas edema (grade 1 or 2) was only observed in 3 animals.

Any other information on results incl. tables

Table1: body weight (kg)
rabbit Day 0 Day 14
1 2 1.8
2 2.4 2.3
3 2.2 2
4 2.2 2
5 2.2 2.2
6 2.2 2.4
7 2.5 2.6
8 2.3 2.5
9 1.9 2.1
10 2.1 2

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008