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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
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

Constituent 1
Chemical structure
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:
(3R,3aR,6S,6aR)-3,6-dimethoxy-hexahydrofuro[3,2-b]furan
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

Resultsopen allclose all
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
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 ha)

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.