Hexamethylene diacrylate

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

: occlusive conditions for 24 h; no data on body weight, clinical signs and gross pathology.

GLP compliance:

no

Remarks:

; GLP was not compulsory at the time the study was conducted.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexamethylene diacrylate

EC Number:

235-921-9

EC Name:

Hexamethylene diacrylate

Cas Number:

13048-33-4

Molecular formula:

C12H18O4

IUPAC Name:

hexane-1,6-diyl bisacrylate

Details on test material:

- Name of test material (as cited in study report): HDODA SN-1258; 1,6-hexanediol diacrylate
- Analytical purity: no data given

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

The animals were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified. After weighing the animal the calculated dose was applied and the entire area covered with rubber dam and held in place by tape.

Duration of exposure:

24 h

Doses:

0.315, 0.795, 1.99 and 5.0 ml/kg bw

No. of animals per sex per dose:

4 animals per dose (only 3 at 1.99 mg/kg bw)

Control animals:

other: the untreated sites of the same animal served as control

Details on study design:

24 h after exposure, the binders were removed and an effort made to remove any remaining material from the skin surface.
A score of the local effects, according to the method of Draize, was recorded. The animals were observed repeatedly for seven days at the end of which time they were sacrificed. Necropsy was performed and samples of any abnormal tissues were preserved in 10 % formalin for possible future histopathologic examination.

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 650 mg/kg bw

Remarks on result:

other: original value given as 3.6 ml/kg bw

Mortality:

No deaths occured at doses of 0.315 and 0.795 mL/kg bw. At 1.99 mL/kg bw one animal out of three died and at 5.0 mL/kg bw two out of four animals died.

Clinical signs:

other: no data given

Gross pathology:

no data given

Other findings:

The test material produced only slight to moderate erythema and edema and was not scheduled for the primary skin irritation test

Applicant's summary and conclusion

Conclusions:

The LD50 for acute dermal toxicity in rabbit was 3650 mg/kg bw 1,6-Hexanediol Diacrylate (original value was given as 3.6 ml/kg bw) under the experimental test conditions chosen.
Therefore, the test material fulfils the requirements to be classified as Category 5 according to GHS-UN criteria. According to EU criteria (1272/2008/EC), a non-classification is warranted.