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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was based on a Draft testing guideline. However, the study was not conducted under GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978. However, the skin sites were exposed under occlusion fo 24 hr which is significantly more severe than the recommendations of the current U.S.E.P.A. and O.E.C.D. Testing Guidelines for Skin 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand White rabbits were received from Kleintierfarm Madorin AG, and weighted 2 to 3 kgs. The rabbits were housed individually in metal cages. The animal room was maintained at 22 +/- 2 degrees C with a relative humidity of 45 to 65 % and 12 hr light/dark cycle. The animals were offered standard rabbit feed (NAFGA, No. 814, Gossau SG) and water ad libitum. The animals were acclimated for four dyas before being placed on study.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded shaved skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml undilute

Duration of treatment / exposure:

24 h

Observation period:

14 d

Number of animals:

3 male, 3 female

Details on study design:

Before treatment was initiated the entire back and flank of the rabbits were shaved with an electric clipper. One side of each rabbit was abraded immediately before exposure. Gauze patches of 2.5 x 2.5 cm with 0.5 ml test substance were applied to both abraded and intact skin sites. The gauze patches were occluded with an impermeable material and fastened to the body with adhesive tape. Following the 24 hr exposure period the dressings were removed and the sites were observed for signs of dermal irritation. Further scoring of dermal irritation was conducted at 24 and 72 hr post-treatment and on study days 7, 10 and 14.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h + 72h

Score:

4.1

Max. score:

4.7

Irritant / corrosive response data:

Edema and erythema scores ranged from 1.5 to 2.7 at 24 to 72 hr. Slightly ischemic areas were observed on 9 of the 12 application sites after 2 - 3 days. These sites developed scales or cracks later in the study.

Any other information on results incl. tables

	MEAN REACTION SCORE				Total
Time after exposure hours	erythema		edema
	intact skin	abraded skin	intact skin	abraded skin
24	2.0	2.0	1.5	1.6
72	2.5	2.7	1.8	2.3
Sums	4.5	4.7	3.3	3.9	16.4

primary irritation index = 16.4 / 4 = 4.1

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under the conditions of the present experiment 1,6-Hexanediol Diglycidylether was found to cause a marked irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 4.1. However, the conditions of this study were severe and would not be employeed today for the accessment of skin irritation potential.

Executive summary:

1,6-Hexanediol Diglycidylether (HDDGE) was accessed for skin irritation potential in rabbits following an older (1978) Draft U.S.E.P.A. Testing Guideline study that used a 24 hr occluded treatment. Under the conditions of the present experiment 1,6-Hexanediol Diglycidylether was found to cause a marked irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 4.1. However, the conditions of this study were severe and would not be employeed today for the accessment of skin irritation potential.