2-ethylhexanoic acid, monoester with propane-1,2-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxypropyl 2-ethylhexanoate

EC Number:

261-499-0

EC Name:

2-hydroxypropyl 2-ethylhexanoate

Cas Number:

58921-10-1

Molecular formula:

C11H22O3

IUPAC Name:

2-hydroxypropyl 2-ethylhexanoate

Constituent 2

Reference substance name:

1-hydroxypropan-2-yl 2-ethylhexanoate

Molecular formula:

C11H22O3

IUPAC Name:

1-hydroxypropan-2-yl 2-ethylhexanoate

impurity 1

Reference substance name:

Monoesters of 2-ethylhexanoic acid and dipropyleneglycol

IUPAC Name:

Monoesters of 2-ethylhexanoic acid and dipropyleneglycol

impurity 2

Reference substance name:

1-methylethylene 2-ethylhexanoate

EC Number:

301-185-3

EC Name:

1-methylethylene 2-ethylhexanoate

Cas Number:

93981-97-6

Molecular formula:

C19H36O4

IUPAC Name:

propane-1,2-diyl bis(2-ethylhexanoate)

impurity 3

Reference substance name:

2-ethylhexanoic acid

EC Number:

205-743-6

EC Name:

2-ethylhexanoic acid

Cas Number:

149-57-5

Molecular formula:

C8H16O2

IUPAC Name:

2-ethylhexanoic acid

impurity 4

Reference substance name:

Propane-1,2-diol, propoxylated

EC Number:

500-039-8

EC Name:

Propane-1,2-diol, propoxylated

Cas Number:

25322-69-4

IUPAC Name:

Propane-1,2-diol, propoxylated

impurity 5

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity. Very slight erythema was noted at the test sites of two males and three females up to nine days after dosing. Small superficial scattered scabs were also noted at the test site of one female seven to nine days aft

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 >2000 mg/kg