1-O-β-(2 ,3-di-O-alka(e)noyl-6 -O-acetyl-D-mannopyranosyl)-D-erythritol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 February - 05 April 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Its a non-GLP study with deviation from OECD 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Deviations:

yes

Remarks:

the temperature and humidity ranges are outside Guideline specifications.

GLP compliance:

no

Remarks:

The experiment was performed in 2007, therefore pre-dating 1st June 2008 cut off after which GLP compliance is necessary for toxicological tests. The report is dated 2019, because this is when the report itself was finalised.

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

126482-45-2

Test material form:

liquid

Details on test material:

Storage of test material: in a tightly sealed container, under refrigeration
Informal name: MEL-2

Test animals

Species:

rabbit

Strain:

other: Kbl:NZW{SPF}

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama Labes Co., Ltd..
- Females (if applicable) nulliparous and non-pregnant: Not stated
- Age at study initiation: 16 - 17 weeks
- Weight at study initiation: 3.37 – 3.82 kg
- Fasting period before study: yes (17 hour)
- Housing: Animals were individually housed in wire mesh cage, 30.5W×49.5D× 33.5H (cm), One animal/cage (during the study).
- Diet (e.g. ad libitum): RC4
(Oriental Yeast, Lot No. 060821)
- Water (e.g. ad libitum): tap water from automated water supply system ad libitum. 

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0−27.0°C
- Humidity (%): 35.0−75.0%
- Air changes (per hr): 8 or more times air changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: 27/2/ 2007 – 9/3/2007

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 & 72 hours after patch removal

Number of animals:

3

Details on study design:

One side of a 2.45 cm-sq patch (lint, Hasegawamenkou) was applied with 0.5 mL of undiluted test item, the patch was held in place for 4 hrs in the dorsal skin of each animal. The residual test substance was removed from the test side. Observations was made at 1, 24, 48 & 72 hours after patch removal .

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

plus eschar

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other:

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

erythema score

Remarks:

plus eschar

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: irritant

Remarks on result:

probability of mild irritation

Results 3

Irritation parameter:

erythema score

Remarks:

plus eschar

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

other: Irritant

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: Irritant

Remarks on result:

probability of mild irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: Irritant

Remarks on result:

probability of mild irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: Irritant

Remarks on result:

probability of mild irritation

Results 7

Irritation parameter:

erythema score

Remarks:

plus eschar and edema

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of mild irritation

Results 8

Irritation parameter:

erythema score

Remarks:

plus eschar and edema

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of mild irritation

Results 9

Irritation parameter:

erythema score

Remarks:

plus eschar and edema

Basis:

animal #3

Time point:

other: 1 Hour

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

The substance is not corrosive but was a mild irritant according to the P.D.I.I.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the condition of the study, the primary irritation index (P.D.I.I.) of the test item was 1.4 ('Mild irritant'), following exposure to clipped rabbit skin under semi-occlusive conditions. However, the test item does not meet the criteria for classification according to the Globally Harmonized Classification System or the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

Executive summary:

OECD 404 (2019): The irritant or corrosive effects of the test item, was assessed following application to the clipped skin of white New Zealand rabbits. On one side of a 2.45 cm-sq patch (lint, Hasegawamenkou) was applied with 0.5 mL of undiluted test item, the patch was held in place for 4 hrs on the dorsal skin of each animal. The residual test substance was removed from the test side. Observations were made at 1, 24, 48 & 72 hours after patch removal and the skin response scored and the degree of skin irritation was classified according to the categories of Gad and Chengelis method.

Both erythema (score: 1) and  edema (score: 1) were observed on 3 tested sites at 1 hour after removal. At 24 hour after patch removal, erythema (score: 2 or 1) was found on 3 test sites, and edema (score 1) was observed on 3 test sites. Erythema (score 1) was found on 3 test sites at 48 and 72 hours after patch removal, however, all of the edema disappeared at 48 hours.

Based on the conditions of this study, the test item was non-corrosive but caused mild irritation to the rabbits' skin according to the categories of skin irritation by Gad and Chengelis method (P.D.I.I. = 1.4). However, under the conditions of the study, it was concluded that the test item does not meet the criteria for classification according to the Globally Harmonized Classification System or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.