Hexamethylene diacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

[volume of 0.05 ml applied (OECD: volume of 0.1 ml); 2 animals were used (OECD: 3); observation period was 8 days (OECD: 21); examination using fluorescein (OECD: no use of fluorescein)]

Principles of method if other than guideline:

BASF-TEST:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl of the test substance were applied to the conjunctival sac of one eye of each of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405.

GLP compliance:

no

Remarks:

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

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:

1,6-Hexanedioldiacrylate (technical grade)
- Name of test material (as cited in study report): HDA2
- Physical state: liquid
- Analytical purity: technical grade
- Stability under test conditions: stabilized, spontaneous degradation or polymerization is not expected

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.09 kg, 2.81 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the second eye of the same rabbit was treated with 50 µl NaCl saline

Amount / concentration applied:

undiluted
Amount applied: 0.05 ml

Duration of treatment / exposure:

24 h; the substance was not washed out

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2 animals, 1 male and 1 female

Details on study design:

50 µl of the undiluted test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye treated with physiological saline served as a control. The substance was not washed out.
Ocular reactions were recorded 10 min, 1, 3 and 24 hours, as well as 2, 5, 7 and 8 days after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the BASF scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours after application. At day 8, the eyes were additionally examined by using fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Other effects:

Details on irritation response:
In both tested animals secretion was observed in the substance-treated eye up to 3 hours after instillation of the test substance.
Both animals showed slight redness of conjunctivae during the first 5 days (see table 1). However, this effect was fully reversible within 7 days. Cornea and iris were inconspicious.
The left eye of both animals which was treated with saline and served as control showed no effects.

Any other information on results incl. tables

Table 1: Eye irritation parameters; the scores of the BASF study were converted according to the method of Draize

Reading time point	Animal 1, treated eye (right)
	Cornea score	Iris score	Conjunctiva Redness	Conjunctiva Chemosis	Additional findings
10 min	0	0	1	0	secretion
1 h	0	0	1	0	secretion
3 h	0	0	1	0	secretion
24 h	0	0	1	0
48 h	0	0	1	0
5 d	0	0	1	0
7 d	0	0	0	0
8 d	0	0	0	0
Reading time point	Animal 2, treated eye (right)
	Cornea	Iris	Conjunctiva Redness	Conjunctiva Chemosis	Additional findings
10 min	0	0	1	0	secretion
1 h	0	0	1	0	secretion
3 h	0	0	1	0	secretion
24 h	0	0	1	0
48 h	0	0	1	0
5 d	0	0	1	0
7 d	0	0	0	0
8 d	0	0	0	0

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test, the test material does not fulfil the requirements to be classified according to EU (as conjunctivae score < 2.5) or GHS (as conjunctivae score < 2) criteria.