1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Feb - 1 Mar 1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Only limited information regarding the test material, animals and environmental conditions is available. Test animals were observed for 3 days post-application, which is a deviation from the OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Only limited information regarding the test material, test animals and environmental conditions is available. Animals were only observed for 3 days after exposure with the test material.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

EC Number:

226-159-8

EC Name:

1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

Cas Number:

5306-85-4

Molecular formula:

C8H14O4

IUPAC Name:

1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 4100 – 4800 g

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 h

Observation period:

3 days
Reading time points: 24 and 72 hours

Number of animals:

2 males and 4 females

Details on study design:

TEST SITE
- Type of wrap if used: The test material was placed on a one-inch square gauze patch. Each patch was applied to the bare (closely clipped) skin of the rabbit and hold in place with masking tape. Four individual patches containing different materials were applied to the back of each rabbit tested. The patches were further covered with a cloth wrapped completely around the trunk of the rabbit and held in place with safety pins. Three intact and three abraded skin areas were treated with 100% DMI.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The bandage and patches were removed and excess material was removed by washing the back of the animal with water.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

One animal (abraded skin) showed slight erythema (grade 1) 24 hours after removing of the test material, but was fully reversible within 72 hours. Therefore, the test material is considered not to be irritating.

Any other information on results incl. tables

Table 1: Individual Dermal Irritation Scores

Observation time	Rabbit no.
	1		2		3		4		5		6
	intact skin		intact skin		intact skin		abraded skin		abraded skin		abraded skin
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	0	0	0	0	0	0	0	0	1	0	0	0
48 h^a)	0	0	0	0	0	0	0	0	1	0	0	0
72 h	0	0	0	0	0	0	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0	0	0	0	0	0	0	0	0.67	0	0	0

a) No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of the Acute Dermal Irritation/Corrosion Test in rabbits the test substance does not possess any skin irritating potential.