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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 14, 1993 - August 19, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study predates and contains a few minor deviations from the current guideline study. However, the study is similar to a OECD 404 study and it is performed according to EPA TSCA Good Laboratory Practice Standards (40 CFR 792).

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The exposure period of test substance. Reversibility of skin ractions were not recorded. Age of animals and their weight at the end of study missing. Two other test substances were tested concurrently on separate test sites on these rabbits
Principles of method if other than guideline:
Exposure time of the test substance was 24 hours (OECD 404; 4 hours) and the test sites were evaluated for erythema, edema and other evidence of dermal effects at 24, 48 and 72 hours (OECD 404; 1, 24, 48, 72 hours after patch removal) after application of the test substance. Two other test substances were tested concurrently on separate test sites on these rabbits. Age of the animals were not mentioned at start of the study and weight of the animals were not measured at conclusion of the study. Furthermore, clinical signs were not reported and the reversibility of skin reactions were not observed up to 14 days after removal of the patches.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Titanium tetra(octanolate), branched and linear
EC Number:
281-199-3
EC Name:
Titanium tetra(octanolate), branched and linear
Cas Number:
83897-91-0
Molecular formula:
C32H68O4Ti, molecular weight range not applicable (UVCB substance)
IUPAC Name:
titanium tetra(octanolate), branched and linear
Details on test material:
- Name of test material (as cited in study report): H20206
- Substance type: organometallic
- Physical state: liquid
- Analytical purity: 100%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey
- Weight at study initiation: 2638 - 3293g
- Housing: singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): conventional laboratory diet ad libitum. During exposure period of 24hours animals did not have access to food.
- Water (e.g. ad libitum): drinking water ad libitum. During exposure period of 24hours animals did not have access to food.
- Acclimation period: two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 2°C
- Humidity (%): 50% +/- 10%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2-inch gauze square
- % coverage
- Type of wrap if used: piece of rubber sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and soap
- Time after start of exposure: 24 hours

SCORING SYSTEM:
The application site was examined for erythema and oedema according to the Draize technique.

Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1 (slight)
Well-defined erythema 2 (mild)
Moderate to severe erythema 3 (moderate)
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4 (severe)

Edema formation:
No edema 0
Very slight edema (barely perceptible) 1 (slight)
Slight edema (edges of area well defined by definite raising) 2 (mild)
Moderate edema (raised approximately 1.0 mm) 3 (moderate)
Severe edema (raised more than 1.0 mm extending beyond the area of exposure) 4 (severe)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
8
Reversibility:
no data
Remarks on result:
other: The scores are the sum of mean erythema and edema scores
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
1.2
Max. score:
8
Reversibility:
no data
Remarks on result:
other: The scores are the sum of mean erythema and edema scores
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
1.5
Max. score:
8
Reversibility:
no data
Remarks on result:
other: The scores are the sum of mean erythema and edema scores
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
1.2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
Table 1 Individual skin irritation scores

Skin responses observed in test rabbits following topical exposure to H-20206
Rabbit Erythema Edema
Number 24 hr 48 hr 72 hr 24 hr 48 hr 72 hr
28096 1 2 2 0 0 0
28223 1 1 2 0 0 0
28179 1 1 1 0 0 0
28100 1 1 1 0 0 0
28101 1 1 1 0 0 0
28184 1 1 2 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The primary dermal irritation/corrosion potential of Titanium tetra(octanolate), branched and linear was evaluated when applied to the skin of rabbits for 24 hours. By the study report, the test substance was a mild skin irritant under conditions of this study.
Executive summary:

This study was regarded reliable with restrictions since there was a few minor deviations from current guideline study (two other test substances were tested concurrently on separate test sites on these rabbits, clinical signs were not reported, test substance exposure time was 24h, animals were not observed to determine reversibility of skin reactions and there was not available physicochemical properties of test material).

Slight erythema was observed in all six rabbits by 24 hours following application. By 48 hours, slight erythema was observed in 5 rabbits and mild erythema in 1. By 72 hours, 3 rabbits exhibited mild erythema. No edema was observed throughout this study. By the study report the test substance is evaluated a mild skin irritant. The result of this study is used as a key value in hazard assessment.

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