Bis(1-methylheptyl) adipate

Acute Toxicity: dermal

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: Basic data given. The test was performed on intact and abraded skin. Test substance purity not given.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

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

Test material information

Constituent 1

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 intact 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

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 intact skin: Diarrhoea was seen for animal 1 at days 9 and 10 and for animal 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.