Reaction mass of (Z)-3-(9-octadecenyloxy)propane-1,2-diol and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-di[oxy[(hydroxymethyl)-1,2-ethanediyl]] and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-tri[oxy[(hydroxymethyl)-1,2-ethanediyl]]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16-31 October 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study conducted in compliance with OECD Guideline 404 with minor deviations: age of the animals not reported; no details on the housing conditions; individual animal weights not reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

age of the animals not reported; no details on the housing conditions; individual animal weights not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

COFRAC accredidation on technical ability

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

9022-76-8

Details on test material:

- Name of test material (as cited in study report): CHIMEXANE NB - Batch M 752
- Physical state: Yellow viscous liquid
- Analytical purity: 98 %
- Lot/batch No.: M 752
- Date received: 09 October 1995
- Storage condition of test material: At room temperature, away from the light and heat

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bertho, Yffiniac, France
- Average weight at study initiation: 2.3 kg
- Housing: Individual housing on floor grid
- Diet (e.g. ad libitum): Complete pelleted rabbit maintenance diet Energie H326, COFNA (Tours, France)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- In accordance with the requirements of the 86/609/EEC guideline.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk of the animals
- Type of wrap if used: Test substance was applied directly to the clipped skin under a gauze pad (2 cm X 2 cm) and held in place by means of a 5 x 5 cm wide ‘Micropore’ fastening tape. Then the animal's trunk was wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the dressings, the residual test substance was removed using absorbent paper moistened with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Scoring system same as recommended by OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritant / corrosive response data:

Well defined erythema to moderate-severe erythema associated with slight to moderate oedema was observed in all 3 animals. These reactions decreased after 7 days and were completely reversible in one rabbit. Very slight erythema and oedema were perceptible respectively in one and two animals up to Day 15.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Individual skin reactions

 

Animal no.	Observation time				Mean (24, 48 and 72 h)
	1 h	24 h	48 h	72 h
Erythema
1	2	3	3	3	3
2	2	3	3	3	3
3	3	3	3	2	2.7
Oedema
1	2	2	3	3	2.7
2	2	3	3	3	3
3	2	3	3	2	2.7

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, CHIMEXANE NB - Batch M 752 is classified as ‘R38 Irritating to skin’ according to the criteria of Annex VI of the Directive 67/548/EEC and ‘Category 2: skin Irritant’ according to CLP Regulation (EC) N° (1272-2008).

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 , three male New Zealand White rabbits were dermally exposed to 0.5 mL of CHIMEXANE NB - Batch M 752, under a semi-occlusive dressing (2 cm x 2 cm) for 4 h to clipped skin of the dorsal area of the trunk. After removal of the dressings, the residual test substance was removed using absorbent paper moistened with water. Irritation was scored as outlined in the OECD Guideline 404 at approximately 1, 24, 48 and 72 h after removal of the dressing and then daily until the end of the observation period (Day 15).

 

Well defined erythema to moderate-severe erythema associated with slight to moderate oedema was observed in all 3 animals. These reactions decreased after 7 days and were completely reversible in one rabbit. Very slight erythema and oedema were perceptible respectively in one and two animals up to Day 15. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 3, 3, 2.7 for erythema and 2.7, 3, 2.7 for oedema score, respectively. In this study, CHIMEXANE NB - Batch M 752 is a skin irritant on male rabbits.

 

Under the test conditions, CHIMEXANE NB - Batch M 752 is classified as ‘R38 Irritating to skin’ according to the criteria of Annex VI of the Directive 67/548/EEC and ‘Category 2: skin Irritant’ according to CLP Regulation (EC) N° (1272-2008).