2-butyl-4,4,6-trimethyl-1,3-dioxane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted in 1980.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.

GLP compliance:

no

Remarks:

The study pre-dates GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Herboxane

IUPAC Name:

Herboxane

Test material form:

other: liquid

Details on test material:

- Name of test material: Herboxane

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Intact and abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

12 rabbits

Details on study design:

Protocol for Primary skin irritation test
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
Twelve healthy adult New Zealand White albino rabbits are used for 1 - 4 test substances. Twenty four hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 ml (in case of liquids) or 0.5 g (in case of solids or semi-solids) of the test substance is brought on the intact or abraded skin under a surgical patch measuring l inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377 - 390). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and or necrosis. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the CIVO grading system.

Evaluation of skin reactions (Draize) Value
A. Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
B. Edema formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2

Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Total possible score for primary irritation: 8 (4 + 4)

Evaluation of skin reactions (CIVO) Value
No reaction at all 0
Very slight scaliness 1
Distinct scaliness or very slight incrustation 2
Distinct incrustation 3
Severe incrustation 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

erythema score

Basis:

animal: 8416

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

animal: 8417

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 4

Irritation parameter:

erythema score

Basis:

animal: 8418

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 5

Irritation parameter:

erythema score

Basis:

animal: 8419

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 6

Irritation parameter:

erythema score

Basis:

animal: 8420

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 7

Irritation parameter:

erythema score

Basis:

animal: 8421

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0.16

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 9

Irritation parameter:

edema score

Basis:

animal: 8416

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 10

Irritation parameter:

edema score

Basis:

animal: 8417

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 11

Irritation parameter:

edema score

Basis:

animal: 8418

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 12

Irritation parameter:

edema score

Basis:

animal: 8419

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 13

Irritation parameter:

edema score

Basis:

animal: 8420

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 14

Irritation parameter:

edema score

Basis:

animal: 8421

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: Intact skin

Results 15

Irritation parameter:

other: Evaluation of Skin Reaction - CIVO

Basis:

mean

Time point:

72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Intact skin

Results 16

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1.6

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Abraded skin. One animal died during the test.

Results 17

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0.2

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Abraded skin. One animal died during the test.

Results 18

Irritation parameter:

other: Evaluation of Skin Reaction - CIVO

Basis:

mean

Time point:

72 h

Score:

1.4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: Abraded skin. One animal died during the test.

Results 19

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.25

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: score based on 24h and 72h skin observation (not measured at 48h)

Results 20

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.25

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score based on skin observation at 24h and 72h (not measured at 48h)

Irritant / corrosive response data:

The skin reactions observed after 24 hours consisted of very slight erythema or well—defined erythema together with very slight edema.
The skin reactions observed after 72 hours consisted of slight to distinct scaliness.
There were no distinct differences between the skin reactions of the intact skin and those of the abraded skin.
From the results of the primary skin irritation test it is concluded that Herboxane is a slight primary skin irritant.

Any other information on results incl. tables

One rabbit died during the exposure period probably because of amechanical trauma.

The individual and average skin irritation scores are presented inthe table below:

Rabbit Number	Intact Skin			Rabbit Number	Abraded Skin
	24 hr		72 hr		24 hr		72 hr
	a	b			a	b
8416	1	0	2	8410	1	0	2
8417	0	0	0	8411	*	*	*
8418	1	0	1	8412	4	1	1
8419	1	0	2	8413	1	0	2
8420	2	1	2	8414	1	0	0
8421	1	0	1	8415	1	0	2
average	1.2		1.3		1.4		1.4

 

Where: A=erythema, B=edema, *=dead

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded that Herboxane is a slight primary skin irritant

Executive summary:

The product Herboxane was examined for primary skin irritating properties and acute dermal toxicity in experiments with albino rabbits.

It was concluded that Herboxane is a slight primary skin irritant.