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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:
15 Oct 1991 - 29 Oct 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Cetyl-2-Ethylhexanoate. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): cetyl-2-ethylhexanoate
- Physical state: colourless liquid
- Analytical purity: not given
- Lot/batch No.: 120300
- Expiration date: December 31st, 1991
- Storage: at room temperature

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb: HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2540 g
- Housing: individual
- Diet: Ssniff rabbit diet K4, Ssniff GmbH, Soest, Germany; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
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 days
Reading time points: 1, 24, 48, 72 h and 7 and 14 days after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the left or right flank
- Type of wrap if used: gauze patch covered with an adhesive air- and vapor-permeable patch and fixed by using a hypoallergenic adhesive gauze-bandage.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3 showed the same mean value for the 3 readings
Time point:
other: mean over 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Table 1: Evaluation of the dermal reaction

Skin effect

Erythema

Edema

 

1h

24h

48h

72h

Meana

1h

24h

48h

72h

Meana

Animal No.

#1

 

1

 

1

 

1

 

2

 

1.3

 

1

 

1

 

1

 

2

 

1.3

#2

1

1

2

2

1.7

1

1

1

2

1.3

#3

1

1

2

3

2.0

1

1

1

2

1.3

amean of readings at 24, 48 and 72 hours

 

Skin effect

days after exposure

 

7

14

Animal No.

#1

 

i b S

 

+

#2

i b S

+

#3

i b S

+

i = irreversible

b = brownish

S = eschar

+ = reversible

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified