Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1
Reference substance name:
D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess)
IUPAC Name:
D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess)
Constituent 2
Reference substance name:
928-176-2
EC Number:
928-176-2
IUPAC Name:
928-176-2
Details on test material:
- Name of test material (as cited in study report): trade name given
- Physical state: white solid
- Analytical purity: 100% AS
- Composition of test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
- Lot/batch No.: 9235138038
- Storage conditions: at room temperature, dark

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb: HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Age at study initiation: 16 months
- Weight at study initiation: 2.85 kg
- Housing: individually
- Diet: Ssniff rabbit diet K4 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days (1 animal) and 14 days (2 animals)

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: sheared
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g (moistened with 1 g distilled water)


Duration of treatment / exposure:
4 h
Observation period:
72 h
reading time points: 1, 24, 48 and 72 h and 21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: the adhesive gauze patch was held in place with a hypo-allergenic adhesive gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was rinsed with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Other effects:
No further local or systemic effects were observed.

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