Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented. Data is suitable for read-across.

Data source

Reference
Reference Type:
publication
Title:
Studies on the design of animal tests for the corrosiveness of industrial chemicals
Author:
Potokar M, Grundler OJ, Heusener A, Jung R, Mürmann P, Schöbel C, Suberg H, Zechel HJ
Year:
1985
Bibliographic source:
Fd. Chem. Toxic. 23(6): 615-617

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 2002)
Deviations:
yes
Remarks:
(6 animals were tested, local reactions were examined after 1 and 4 h, occlusive and semi-occlusive dressing was used)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Titanium tetrachloride
- Analytical purity: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Various breeders, not specified
- Weight at study initiation: 2-4 kg
- Housing: Individually
- Diet: Ad libitum (except during exposure), standard rabbit feed
- Water: Ad libitum (except during exposure)


ENVIRONMENTAL CONDITIONS
Standardised laboratory conditions, no further data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
1 and 4 hours
Observation period:
7 days
Number of animals:
6 for each exposure time
Details on study design:
TEST SITE
- Area of exposure: Dorsal and lateral parts of the trunk
- % coverage: Unspecified, gauze pads with 3x3 cm were used
- Type of wrap if used: Air permeable circular bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with water and dried
- Time after start of exposure: Either after 1 or 4 hours


SCORING SYSTEM: As described in the OECD guideline 404

Results and discussion

In vivo

Results
Irritation parameter:
other: full thickness destruction
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: 1 h
Reversibility:
not reversible
Remarks on result:
other: Score n.a.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information