Bis(1-methylheptyl) adipate

Acute Toxicity: oral

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:

data from handbook or collection of data

Justification for type of information:

Equivalent to or similar to a guideline study; not performed under GLP auditing procedures.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity guideline; not specifically noted. Described as similar to 401.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(1-methylheptyl) adipate

EC Number:

203-601-8

EC Name:

Bis(1-methylheptyl) adipate

Cas Number:

108-63-4

Molecular formula:

C22H42O4

IUPAC Name:

bis(1-methylheptyl) adipate

Test material form:

liquid

Details on test material:

Manufacturer's commercial samples, samples from various production batches

Specific details on test material used for the study:

hexanedioic acid, bis(1-methylheptyl ester), CAS 108-63-4. Purity not indicated.

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

rats, weights 200-300 grams. No information on housing conditions or on caging by gender. Males
and females were distributed equally.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Single oral (gavage) administration. No controls. Feeding ad libitum, but food was withheld for 24 h
prior to dosing.

Doses:

2, 4, 8, 16, 32, 64 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Single oral (gavage) administration. No controls. Feeding ad libitum, but food was withheld for 24h prior to dosing. Observations extended for 14 days. Clinical signs were noted daily. No measurement of body weight or postmortem examinations were undertaken.

Statistics:

No statistics used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 64 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was seen only in the highest dose group of 64 g/kg: 2/5 animals died.

Clinical signs:

Clinical signs were seen in all 6 dose groups, including sluggish locomotion, lethargy, ocular swelling
and wet scruffy rough fur. Survivors returned to normalcy within seven days.

Body weight:

No measurement of body weight was reported.

Gross pathology:

No postmortem investigation was reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The registered substance was tested for acute oral toxicity in rats and displayed an LD50 value of 64,000 mg/kg bw. The substance is not classified for oral toxicity according to Regulation EC No. 1272/2008.