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Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Acute dermal toxicity study
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
This study was carried out by Japanese government to confirm its toxicity.
Qualifier:
no guideline available
Version / remarks:
The study was carried out refer to OECD guideline, but guideline number was not specified.
Principles of method if other than guideline:
Similar to OECD 434
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Titanium trichloride is unstable substance and gradually decomposes at room temperature. Thus, the solution prepared by dissolving titanium in the hydrochloric acid solution was used as test material.
This solution was dark violet liquid and its density was 1.28 g/ml. the concentration was over 20%.
Species:
rat
Strain:
Wistar
Remarks:
Slc
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Japan SLC
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 week
- Weight at study initiation: Not known
- Fasting period before study:
- Housing:Metal cage (w 220 x D 220 x H170 mm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24±1
- Humidity (%): 55 ± 5
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hours light
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the body
- % coverage: approximately 10%
- Type of wrap if used: The test solution was spread on the lint cloth and be hold on the dorsal skin. The cloth was covered with aluminum foil and fixed with Tegaderm transparent dressing tape(Sumitomo 3M). In addition that, the trunk of the animal was swathed with Reston self-adhering foam pads (Sumitomo 3M) and Silkytex adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000 mg/kg as 20% titanium trichloride solution.
- Concentration (if solution): 20, 50 and 100 %
- Constant volume or concentration used: yes; constant concentration
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): not known.
- Concentration (if solution):25, 50 and 100%
- Lot/batch no. (if required): not available
- Purity:not known
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 rats per sex and dose.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:not known
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
not used
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks:
as 20 % solution
Mortality:
No
Clinical signs:
No abnormal signs were observed during exposure period.
Body weight:
Not known
Gross pathology:
Necropsy of all animals on 14th day was carried out. MIcroscopic examination of organs did not show any change.
Other findings:
Observation of skin after removal of the lint cloth, which contained test chemical.
The skin of contact area was seriously corroded and the skin was adhered on the lint cloth and bled for both male and female animals.
After 2nd day, the corroded skin turned to black and began eschar formation. After 5th day, the eschar began to desquamate from the edge of the eschar, but did not disappear even on the 14th day.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity study on titanium trichloride was conducted using 20% hydrochloric acid solution of titanium trichloride.
This solution showed serious skin corrosion, but no mortality was observed even in the dosage 2000 mg/kg. Thus LD50 was estimated over 2000mg/kg as 20 % solution.
Executive summary:

The acute dermal toxicity study on titanium trichloride was conducted using 20% hydrochloric acid solution of titanium trichloride. This solution showed serious skin corrosion, but no mortality was observed even in the dosage 2000 mg/kg. Thus LD50 was estimated over 2000mg/kg as 20 % solution.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 402 Acute dermal toxicity
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Titanium trichloride
EC Number:
231-728-9
EC Name:
Titanium trichloride
Cas Number:
7705-07-9
Molecular formula:
Cl3Ti
IUPAC Name:
Titanium trichloride Titanium(III) trichloride
impurity 1
Reference substance name:
unknown impurities
IUPAC Name:
unknown impurities
Test material form:
solid: granular
Details on test material:
Purity: 99.6%
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Wako pure chemical industry Co., Ltd. 20wt% hydrochloric acid solution.

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Japan LSC
- Age at study initiation: 11 week
- Weight at study initiation: not known
- Housing:Metal mesh cage w220 x D220 x H170 mm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24±1°C
- Humidity (%): 55 ± 5 %
- Air changes (per hr): 18 times/hr
- Photoperiod (hrs dark / hrs light):12 hrs dark/ 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: aqueous hydrochloride solution
Controls:
no
Amount / concentration applied:
500, 1000 and 2000 mg/kg
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
Not specified
Details on study design:
TEST SITE
- Area of exposure: back 9 x 6 cm
- % coverage: 10 % of body surface area calculated from (0.1 x body weight) ^2/3
- Type of wrap if used: aluminum foil, transparent dressing tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 hours, applied port was washed with warm water to remove test substance completely.
- Time after start of exposure:24 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 hours, 2nd day, 5th day

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: corrosive
Basis:
animal:
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
contact ports were seriously corroded.
Irritation parameter:
other: corrosive
Basis:
animal:
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: change colour and eschar formation
Remarks:
Corroded port was changed its colour to brown and eschar formation began.
Irritation parameter:
other: corrosive
Basis:
animal:
Time point:
other: 5th day
Reversibility:
not reversible
Remarks on result:
other: Eschar separation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Tttanium trichloride solution was very corrosive to the skin.
Executive summary:

In the acute dermal toxicity study, this substance showed very corrosive property to the skin.

So, skin corrosion/irritation study was not carried out.

This material is corrosive to the skin.