Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 Apr - 29 Apr 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
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): methyl hexanoate
- Substance type: Fatty acid methyl ester
- Physical state: liquid, colourless
- Analytical purity: > 98%
- Lot/batch No.: 1291191
- Expiration date of the lot/batch: 24.06.1994
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, CHbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 15 months
- Weight at study initiation: approx. 2540 g
- Housing: individually
- Diet (e.g. ad libitum): Ssniff rabbit diet K4 (Ssniff GmbHm Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
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 hours
Observation period:
22 days
Reading time points: 1, 24, 48, 72 h, day 7, day 14 and day 22
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal skin, 6 cm²
- Type of wrap if used: adhesive air- and vapour permeable semiocclusive dressing (gauze patch fixed with a hypoallergenic adhesive gauze-bandage)

REMOVAL OF TEST SUBSTANCE
The skin was cleaned from residual test substance after removal of the dressing.

SCORING SYSTEM
The Draize scoring system was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 22 days
Remarks on result:
other: At the end of observation period on day 22 slight erythema graded 1 still was seen
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:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: transient eschar formation was noticed on day 7
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 22 days
Remarks on result:
other: at the end of observation period on day 22 slight edema graded 1 still was observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Slight to weak erythema and edema were observed in all three animals from reading time point 1 h to 72 h. One animal displayed transient eschar on day 7. In two cases, full reversibility was achieved with 14 days whereas in the third animal slight erythema and edema graded 1, respectively, still were evident at the end of the observation period of 22 days.

Any other information on results incl. tables

Table 1:  Individual evaluation of skin findings for each of the 3 rabbits used:  

 Animal

Hours after application

1

24

48

72

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

1

0

2

1

2

1

1

1

2

1

0

1

1

2

1

2

1

3

2

2

2

2

2

1

1

1

 

Animal

Days after application

 

7

14

 22

Reversibility

Erythema

Edema

1

not reversible

not reversible

no

1

1

2

not reversible

reversibility achieved

yes

0

0

3

not reversible (transient eschar)

reversibility achieved

yes

0

0

Applicant's summary and conclusion

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