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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 based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
17 Mar - 07 Apr 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions; analytical purity of test substance not given.

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)
Deviations:
yes
Remarks:
analytical purity of test material not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Palmitinsäuremethylester (palmitic acid methyl ester)
- Substance type: Fatty acid methyl ester
- Physical state: solid, pasty, white
- Analytical purity: not indicated
- Impurities: vestige of myristic acid and stearic acid
- Expiration date: 11 July 1992
- Stability under test conditions: stable in pure state for at least 2 years, not stable in water, air and against acid
- Storage condition of test material: room temperature, protected from light

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. 14 months
- Weight at study initiation: approx. 2480 g
- Housing: individual accommodation
- Diet: Ssniff rabbit diet (K4, Sniff GmbH, Soest, Germany; Charge: 770392/02), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- 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 g
Duration of treatment / exposure:
4 h
Observation period:
21 days
Reading time points: 1, 24, 48 and 72 hours, day 7, 14 and 21
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal clipped skin (left resp. right flank), 6 cm²
- Type of wrap if used: air- and vapour permeable gauze-patch fixed with hypoallergenic adhesive gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC), i.e. 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:
1.66
Max. score:
4
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: eschar formation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: slight erythema and eschar persisted until day 21
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 d
Remarks on result:
other: eschar formation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2.66
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 d
Other effects:
There were no sytemic effects reported.

Any other information on results incl. tables

Table 1: Individual erythema and edema scores for each of reading time points 1, 24, 48 and 72 h:

Animal Number

1 h

(erythema/edema)

24 h 

(erythema/edema)

48 h 

(erythema/edema)

72 h 

(erythema/edema)

1

1/0

2/1

2/1

1/1

2

2/1

3

3/3

3/2 (brownish discoloration)

3

1/0

3

3/2

3/3

 

Table 2: Evaluation of findings for each of reading time points 7,14 and 21 days

Animal Number

day 7

day 14

day 21

day 21 (erythema/edema)

1

irreversible/eschar

irreversible/eschar

reversible

0/0

2

irreversible/eschar

irreversible

irreversible

1/0

3

irreversible/eschar

irreversible/eschar

reversible

0/0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Cat. 2, H315
DSD: Xi, R38