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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, adopted November 24, 2000
Deviations:
no
Remarks:
(as this is in line with OECD 404)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-Butylethanolamine
- Homogeneity: The test substance was homogeneous by visual inspection.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: Ca. 7 months
- Weight at study initiation: 3.77 kg – 4.29 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet (about 130 g/animal per day): Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Reasons for the selection of the test species: This animal species is the worldwide accepted test system for skin irritation / corrosion studies.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the undiluted liquid substance.
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flank
- Type of wrap if used: test patch (2.5 cm x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1 : 1).

SCORING SYSTEM:
Erythema and eschar formation
Grading:
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to eschar formation preventing grading of erythema

Edema formation
Grading:
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approx. 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: scaling was observed was observed on day 7 up to day 14 post application
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: severe scaling was observed on day 7 up to day 14 post application
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
not fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Irritant response, data for each individual animal at each observation time as well as calculation of the means.

 

 

Exposure period: 4 h

Readings

Animal

Erythema

Edema

Additional findings

0 h

01

2

0

 

02

2

0

 

03

2

2

 

1 h

01

2

1

15,16

02

2

1

15,16

03

2

2

15,16

24 h

01

3

0

15

02

3

1

15,16

03

3

1

15,16

48 h

01

2

0

15

02

2

0

15

03

3

0

15

72 h

01

0

0

SD

02

2

0

15

03

3

0

15

7 d

02

1

0

S, 15, 17

03

2

0

SS, 15, 18

14 d

02

0

0

S

03

2

0

SS

Mean 24-72 h

01

1.7

0.0

 

02

2.3

0.3

 

03

3.0

0.3

 

Mean

 

2.3

0.2

 

15 = erythema extending beyond the area of exposure

16 = edema extending beyond the area of exposure

17 = scaling extending beyond the area of exposure

18 = severe scaling extending beyond the area of exposure

S = scaling

SD = study discontinued because the animal was free of findings

SS = severe scaling

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
BEA was irritating to skin.
Executive summary:

In a dermal irritation study (BASF, 2007; Report No. 18H0033/072033) according to OECD 404 and GLP the shaved skin of three New Zealand White rabbits was dermally exposed to 0.5 mL of the unchanged test substance for 4 hours under semiocclusive conditions. Animals then were observed for 14 days. Irritation was scored according to the method of Draize. Moderate or marked erythema (grade 2 or 3) was observed in all animals up to 48 hours and in two animals up to 72 hours after removal of the patch. One out of these two animals showed slight erythema (grade 1) on day 7 and the other animal exhibited moderate erythema (grade 2) up to study termination on day 14. Moderate oedema (grade 2) was noted in one animal up to 1 hour after removal of the patch and decreased to slight (grade 1) up to the 24-hour reading. Slight edema was noted in two animals after 1 hour and persisted in one out of them up to 24 hours. Both, erythema and oedema partly extended beyond the area of exposure. In addition scaling and severe scaling, both partly extended beyond the area of exposure, were observed in two animals on day 7 and 14. The results show, that the cutaneous reactions were reversible in one animal within 48 hours after removal of the patch. In another animal the cutaneous reactions with the exception of scaling were reversible within 14 days. The cutaneous reactions were not reversible in the third animal, which exhibited moderate erythema and severe scaling on day 14 (study termination). Mean scores over 24, 48 and 72 hours for each animal were 1.7, 2.3 and 3.0 for erythema and 0.0, 0.3 and 0.3 for oedema.