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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:
08 May - 18 May 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethyldiglykolacetat
- Physical state: liquid
- Analytical purity: 99.8%
- Density: 1.01 g/cm³
- Storage conditions: inert gas atmosphere, dry

Test animals

Species:
rabbit
Strain:
other: Small White Russian (Chbb-SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: individually in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, Germany; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated sites served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on an approx. 6 cm² area of the skin
Duration of treatment / exposure:
4 hours
Observation period:
10 days
Reading time points: 1, 24, 48, and 72 h and 6, 8, and 10 days after application
Number of animals:
3 males
Details on study design:
TEST SITE
- Test site preparation: Approx. 24 h before application, the dorsal and lateral parts of the trunk were clipped (10 x 10 cm).
- Area of exposure: approx. 6 cm² (2.5 x 2.5 cm)
- Type of wrap if used: gauze patch fixed with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, substance residues were washed off softly with warm water.
- Time after start of exposure: 4 hours

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
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean out of all 3 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Only very slight effects (max. score = 1) were observed throughout the study. No edema were seen with the exception of animal #1 at the 1-hour reading. Slight erythema were seen in two animals 1 hour after application which were fully reversible within 72 h and 8 days, respectively.

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