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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Triboron trimethyl hexaoxide
EC Number:
203-016-8
EC Name:
Triboron trimethyl hexaoxide
Cas Number:
102-24-9
Molecular formula:
C3H9B3O6
IUPAC Name:
trimethoxyboroxin
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Trimethoxyboroxin
- pH-value: ca. 5 (undiluted test substance)
- Test substance No.: 04/0710-1
- Lot/batch No.: 559732
- Homogeneity: substance was homogeneous by visual inspection.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 7 - 8 months
- Weight at study initiation: 3.62 - 3 .88 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes: The animals were housed in fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
up to 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flank: 2.5 x 2.5 cm
- Type of wrap if used: a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol® and Lutrol® / water (1 : 1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: according the quoted guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Moderate or marked erythema (grade 2 or 3), observed in all animals immediately after removal of the patch up to 24 hours, persisted in two animals up to 72 hours. Moderate erythema decreased to slight (grade 1) in one animal after 48 hours and in two animals on day 7. Slight erythema persisted in one animal from 48 hours up to day 7.
Moderate edema (grade 2), noted in all animals immediately after removal of the patch up to 1 hour, decreased to slight (grade 1) in two animals after the 24-hour reading.
In addition, scaling was noticed in one animal on day 7.
The cutaneous reactions were reversible in all animals within 14 days after removal of the patch.
Mean scores over 24, 48 and 72 hours for each animal were 1.3, 2.0 and 2.0 for erythema and 0.3, 0.3 and 0.0 for edema.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the criteria as laid down in GHS-UN, the substance can be considered as slightly irritating.

Categories Display