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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:
From 3/3/2006 to 25/10/2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
154518-38-4 (Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters)
IUPAC Name:
154518-38-4 (Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters)
Constituent 2
Chemical structure
Reference substance name:
Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters
EC Number:
800-484-0
Cas Number:
154518-38-4
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
IUPAC Name:
Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters
Constituent 3
Reference substance name:
Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters
IUPAC Name:
Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters
Details on test material:
- Physical state: liquid
- Analytical purity: 100 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Granja Cunícula San Bernardo, S.L
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.3-3.1 Kg
- Housing: individually in a stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the test item
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24, 48,72 hours, 7 and 14 days after the period of exposure.
Number of animals:
three
Details on study design:
Erythematous lesions and eschars (most severely affected areas) - No erythema: 0 - Very slight erythema (hardly noticeable): 1 - Well defined erythema: 2 - Moderate to intense erythema: 3 - Intense erythema (reddening) or formation of eschars that impede scoring: 4 Edematous lesions - No edema: 0 - Very slight edema (hardly noticeable): 1 - Slight edema (the edges of the zone are well defined by concrete elevations): 2 - Moderate edema (1 mm elevations, approximately): 3 - Intense edema (elevations of more than 1 mm and that extend beyond of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: only very slight erythema (grade 1) and slight desquamation remaining
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
3.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Initially after 24 and 48 hours after removal of the patch during 3 minutes well defined erythema (grade 2) was observed, along with very slight edema (grade 1). After 72 hours the erythema had decreased, and only very slight erythema (grade 1) and dryness were recorded. At 7 and 14 days after removing the cited patch, no skin lesions were recorded. After 24, 48 and 72 hours, intense erythema (grade 4) was observed in one of the animals, along with intense edema (grade 4) at 24 and 48 hours, and moderate edema (grade 3) at 72 hours. after 7 days the erythema had decreased to well defined erythema (grade 2) and desquamation was observed on the area administered. After 14 days very slight erythema (grade 1) and slight desquamation were observed in one of the animals.

Any other information on results incl. tables

Bodyweight (kg)

Observation period

Animal no.

Day of treatment

24h

48h

72h

7d

14d

2378

2,73

2,73

2,77

2,73

2,94

3,12

2162

2,31

2,33

2,38

2,43

2,54

2,77

2166

3,14

3,22

3,23

3,28

3,45

3,77

Primary Dermal Irritation Test

Animal no. (Exposure)

Response

60 min

24 h

48 h

72 h

7 d

14 d

2378 (3 minutes)

Erythema

0

2

2

1'

0

0

Edema

0

1

1

0

0

0

2378 (1hour)

Erythema

1

2

2

2'

0

0

Edema

0

2

2

1

0

0

2378 (4hours)

Erythema

3

4

4

4

22,3

0

Edema

4

4

4

4

0

0

1:Dryness

2':Desquamation

3':Areas of epidermal regeneration

Primary Dermal Irritation Test

Animal no. (Exposure)

Response

60 min

24 h

48 h

72 h

7 d

14 d

*2378 (4 hours)

Erythema

3

4

4

4

23,5

0

Edema

4

4

4

4

0

0

2162 (4 hours)

Erythema

3

4

4

4

23

14

Edema

4

4

4

3

0

0

2166 (4 hours)

Erythema

3

3

31

32,3

13

04

Edema

4

3

2

2

0

0

1:Slight dryness

2':Dryness

3':Desquamation

4:Slight desquamation

5:Areas of epidermal regeneration

*: Corresponds to the animal administered, to which 3 patches were sequentially applied.

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
The alterations induced by the test item were evaluated following the OECD Guideline 404 and Method B.4. In view of the results obtained, the test item is considered to be irritant , based on the criteria set out in directive 2001/59/EC, Annex VI, and it is therefore assigned the risk phrase R38. According to CLP, EU GHS (Regulation (EC) No 1272/2008) the test item has to be classified as Category 2 (irritant).
Executive summary:

In a primary dermal irritation study according to the OECD Guideline for the Testing of Chemicals 404 and Commission Directive 2004/73/EC Method B.4, 3 female, young adult New Zealand white rabbits were dermally exposed to 0.5 mL of Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters (100% a.i.) for 4 hours. Animals then were observed for 14 days.

At 60 minutes after removal of the patch exposed during 4 hours, moderate to intense erythema (grade 3) was observed, along with intense edema (grade 4). At 24, 48 and 72 h the erythema had evolved to intense erythema (grade 4), and the intense edema persisted at all the observations.

After 7 days well defined erythema (grade 2) was recorded, along with desquamation and areas of epidermal regeneration. Full recovery was observed after 14 d.

Similar findings were observed on 2 further animals: After 24, 48 and 72 h, intense erythema (grade 4) was observed in one animal along with intense edema (grade 4) at 24 and 48 h and moderate edema (grade 3) at 72 h. After 14 d very slight erythema (grade 1) and slight desquamation were still present in this animal.

Moderate to intense erythema (grade 3) was recorder in the third animal after 24, 48 and 72 h, accompanied with moderate edema (grade 3) at 24 h and slight edema (grade 2) at 48 and 72 h. After 14 d the erythema had remitted, only slight desquamation was observed.

The means of the erythema and edema evaluations at 24, 48 and 72 hours for the three animals after a four-hour exposure were 4/4/3 (erythema) and 4/3.6/2.3 (edema).

In this study, Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters is an skin irritant (Category 2) based on the criteria of Regulation (EC) No. 1272/2008.