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Toxicological information

Skin irritation / corrosion

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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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.