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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 May 2012 - 29 August 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147
Version / remarks:
November 2000; including the most recent partial revisions.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipotassium titanate(2-)
EC Number:
261-919-2
EC Name:
Dipotassium titanate(2-)
Cas Number:
59766-31-3
Molecular formula:
K2O17Ti8
IUPAC Name:
dipotassium titanate(2-)
Test material form:
solid: particulate/powder
Details on test material:
Appearance: White powder
Storage conditions: Room temperature

Test animals

Species:
rat
Strain:
other: CD (Crl:CD 'SD')
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Charles River (UK) Ltd.
- Age at study initiation: Young adult animals (approx. 8-12 weeks old)
- Weight at study initiation: 362-403 g for males, 230-239 for females.
- Housing: Animals were housed individually from Day -1 until Day 4 when they were returned to group housing (in groups of five rats of the same sex).
- Diet: Free access to pelleted rodent diet (Rat and Mouse No. 1 Maintenance Diet).
- Water: Free access to tap water.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – \23
- Humidity (%): 40 - 70
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 June 2012 to 11 July 2012

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
One day before exposure (Day -1) the treatment on the dorso-lumbar region of the animal was clipped, exposing an area equivalent to approximately 10% of the total body surface area.

The test substance was applied by spreading it evenly over the prepared skin. The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

Frequency: Single dosage, on Day 1.

Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water.
Duration of exposure:
24 hours.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Dose volume: 4 mL/kg bw.

DOSAGE PREPARATION: The test substance was formulated at a concentration of 500 mg/mL in the vehicle

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Days 1 (prior to dosing), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: All animals were subject to a macroscopic examination
- Other examinations performed: none.
Statistics:
None.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study.
Clinical signs:
There were no clinical signs noted during the study.
Body weight:
A low bodyweight gain was noted for one female (F8) on Day 8. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination.
Other findings:
No dermal reactions were observed in any animal during the study.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
according to Regulation (EC) 1272/2008
Conclusions:
In an acute dermal toxicity study with rats, performed according to the OECD 402 test guideline, an LD50 >2000 mg/kg bw was determined.
Executive summary:

An acute dermal toxicity study in rats was performed according to the OECD 402 test guideline and in accordance with GLP principles. A group of 10 CD rats (5 males, 5 females) received a single topical application of the test substance, formulated in purified water, at a dose level of 2000 mg/kg bw, for the duration of 24 hours. There were no deaths during the study and no dermal reactions were observed. There were no effects found on bodyweight except for a low bodyweight in one female on day 8. No abnormalities were noted in any animal at the macroscopic examination. The LD50 value of TISMO D was established to exceed 2000 mg/kg bw. Based on these results, according to Regulation (EC) 1272/2008, TISMO D does not have to be classified and has no obligatory labelling required for dermal toxicity.