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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
February 16,1988 to March 02, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 404.
Justification for type of information:
see read across justification
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 16,1988 to March 02, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 404.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Special Diets, Soet, Germany
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of product with 0.5 cm3 water
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: exposure site covered with 2.5 x 2.5 cm patch. 6 x 6 cm Polyethylene wrapping placed on top and fixed with an elastic band.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water directly after patch removal.
- Time after start of exposure: 4 h


SCORING SYSTEM: OECD 404 method
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
3.67
Max. score:
8
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
None
Other effects:
None

Table 1:Skin irritation responses in rabbit exposed to test substance

Animal N°

1 h

24 h

48 h

72 h

6 d

8 d

10 d

14 d

R

S

R

S

R

S

R

S

R

S

R

S

R

S

R

S

1

2

1

2

1

2

1

x2

1

Sc

SciA

0

0

0

0

2

2

2

3

1

2

1

x2

1

Sc

SciA

SciA

0

0

3

2

3

3

2

3

1

x3

1

Sc

SciA

SciA

0

0

R: redness (erythema); S: swelling (oedema); x: spotty skin reaction; Sc: eschar; iA: detaching

Absolute average

4.00, 4.00, 3.33, 3.33 => 14.66/4 =3.67

Assessment according to Appendix VI of Directive 79/831/EC:

Redness (erythema): average = 2.44

Swelling (oedema): average = 1.11

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was considered to be moderately irritating to rabbit skin.
Executive summary:

A study was conducted to assess the skin irritation potential of structurally similar amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) to rabbits according to OECD guideline 404. The diluted test substance was applied to the shaved skin of three rabbits using an occlusive bandage. After 4 hours, the exposed skin was rinsed then observed for 14 days. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 days. The overall irritation index was 3.67 out of 8. Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was considered to be irritating to rabbit skin under the conditions of this study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl
EC Number:
931-338-5
Cas Number:
90622-77-8
Molecular formula:
not applicable
IUPAC Name:
Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl
Constituent 2
Reference substance name:
Amides, C12-18 and C18-unsatd., N-(hydroxyethyl)
EC Number:
292-481-0
EC Name:
Amides, C12-18 and C18-unsatd., N-(hydroxyethyl)
Details on test material:
- Name of test material (as cited in study report): Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl
- Composition:
1. C8+10: ≤3 %
2. C12 : 45 to 60 %
3. C14: 15 to 25 %
3. C16: 5 to 15 %
4. C18: ≤3 %
5. C18’: 5 to 20 %
6. C18’’: ≤4 %

Test animals

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Special Diets, Soet, Germany
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of product with 0.5 cm3 water
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: exposure site covered with 2.5 x 2.5 cm patch. 6 x 6 cm Polyethylene wrapping placed on top and fixed with an elastic band.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water directly after patch removal.
- Time after start of exposure: 4 h


SCORING SYSTEM: OECD 404 method

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
3.67
Max. score:
8
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

Table 1:Skin irritation responses in rabbit exposed to test substance

Animal N°

1 h

24 h

48 h

72 h

6 d

8 d

10 d

14 d

R

S

R

S

R

S

R

S

R

S

R

S

R

S

R

S

1

2

1

2

1

2

1

x2

1

Sc

SciA

0

0

0

0

2

2

2

3

1

2

1

x2

1

Sc

SciA

SciA

0

0

3

2

3

3

2

3

1

x3

1

Sc

SciA

SciA

0

0

R: redness (erythema); S: swelling (oedema); x: spotty skin reaction; Sc: eschar; iA: detaching

Absolute average

4.00, 4.00, 3.33, 3.33 => 14.66/4 =3.67

Assessment according to Appendix VI of Directive 79/831/EC:

Redness (erythema): average = 2.44

Swelling (oedema): average = 1.11

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was considered to be moderately irritating to rabbit skin.
Executive summary:

A study was conducted to assess the skin irritation potential of structurally similar amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) to rabbits according to OECD guideline 404. The diluted test substance was applied to the shaved skin of three rabbits using an occlusive bandage. After 4 hours, the exposed skin was rinsed then observed for 14 days. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 days. The overall irritation index was 3.67 out of 8. Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was considered to be irritating to rabbit skin under the conditions of this study