Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-({[6-({1-chloro-3-[(oxiran-2-yl)methoxy]propan-2-yl}oxy)hexyl]oxy}methyl)oxirane; 2-[({6-[(oxiran-2-yl)methoxy]hexyl}oxy)methyl]oxirane; 3-chloro-2-({6-[(oxiran-2-yl)methoxy]hexyl}oxy)propan-1-ol; 6-[(oxiran-2-yl)methoxy]hexan-1-ol

EC Number:

618-939-5

Cas Number:

933999-84-9

Molecular formula:

C6H14O2 + C3H5ClO

IUPAC Name:

2-({[6-({1-chloro-3-[(oxiran-2-yl)methoxy]propan-2-yl}oxy)hexyl]oxy}methyl)oxirane; 2-[({6-[(oxiran-2-yl)methoxy]hexyl}oxy)methyl]oxirane; 3-chloro-2-({6-[(oxiran-2-yl)methoxy]hexyl}oxy)propan-1-ol; 6-[(oxiran-2-yl)methoxy]hexan-1-ol

Details on test material:

As per IUCLID5 Sections 1.1. - 1.4.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

White rabbits bred and raised at Kleintierfarm Madörin AG, CH-4414 Füllinsdorf, weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 + 2°C, at a relative humidity of 55 + 10 % and on a 12 hour light cycle day. The animals had ad libitum access to standard rabbit feed - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to the laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

14 d

Observation period (in vivo):

14 d

Number of animals or in vitro replicates:

3 male, 3 female

Details on study design:

Approximately 0.1 mL of 1,6-Hexanediol Diglycidylether (HDDGE) was instilld into the conjuntival sac of the left eye of each rabbit. In half of the animals following approximately 30 seconds of treatment, the treated eye was flushed with 10 mL of physiological saline (washed). Eye irritation was scored with the aid of a slit lamp on study days: 1, 2, 3, 4, 7, 10 and 14 following method of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

18.4

Reversibility:

fully reversible

Remarks on result:

other: unrinsed eyes

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 h

Score:

3.3

Reversibility:

fully reversible

Remarks on result:

other: rinsed eyes

Irritant / corrosive response data:

Maximal levels of irritation were observed in the cornea, iris and conjunctiva 24 to 72 hr after treatment. Irritation of the cornea and iris was fully recovered by study day 4. Conjuntival irritation had recovered by study day 10. In the washed rabbit eyes no irritation of the cornea or iris was observed. The washed eye conjunctiva had fully recovered by study day 7.

Any other information on results incl. tables

In the unrinsed eyes, a reversible irritation of the cornea was observed after 24-72 hours. A reversible irritation of the iris was observed after 24 and 48 hours. The irritation of the conjunctiva was strongest after 24 hours and decreased to a negligible level after 14 days. The highest irritation score was 29.7 and was observed after 24 hours. In the rinsed eyes, no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 48 hours. After 7 days all irritation had disappeared.

Time after exposure hours	MEAN REACTION SCORE
	Unrinsed eyes (A)			Rinsed eyes (B)
	cornea	iris	conjunctiva	cornea	iris	conjunctiva
1 2 3 4 7 10 14	16.7 11.7 6.7 0 0 0 0	1.7 1.7 0 0 0 0 0	0 0 0 0 0 0 0	0 0 0 0 0 0 0	0 0 0 0 0 0 0	2 3.3 1.3 1.3 0 0 0

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on conjunctival irritation scores, 1,6-Hexanediol Diglycidylether is a rabbit eye irritant for Classification and Labeling purposes. However, washing of treated eyes with physiological saline prevented significant irritation.

Executive summary:

1,6-Hexanediol Diglycidylether (HDDGE) was accessed for the potential to be a rabbit eye irritant ia a Draize method study. Three of the six aninmals had their treated eye washed with physiological saline approximately 30 seconds following the initiation of treatment. Based on conjunctival irritation scores, 1,6-Hexanediol Diglycidylether is a rabbit eye irritant for Classification and Labeling purposes. However, washing of treated eyes with physiological saline prevented significant irritation.