Potassium titanium oxide (K1.88-2.13Ti8O16.94-17.07)

Endpoint summary

Description of key information

Acute oral toxicity test with female rats (OECD 425, OPPTS 870:1100): LD50 > 2000 mg/kg bw

Acute dermal toxicity test with male and female rats (EC B.3, OECD 402, OPPTS 870:1200): LD50> 5000 mg/kg bw

Acute inhalation test with male and female rats (EC B.2, OECD 403, OPPTS 870.1300): LC50 > 5.2 mg/L air

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 July 2004 to 5 January 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP in accordance with an internationally recognised test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Species:

rat

Strain:

other: Crl:CD®(SD)IGS BR

Sex:

female

Vehicle:

other: Deionised water

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Female: 175 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 550 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross lesions were found in any animal during necropsy.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the oral LD50 was greater than 2000 mg/kg for female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP in accordance with an internationally recognised test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Qualifier:

according to guideline

Guideline:

other: Ministry of Agriculture, Forestry, and Fisheries (MAFF) (1985). 59 NohSan Number 4200, Acute Inhalation Toxicity Study. Testing Guidelines for Toxicity Studies

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:CD®(SD)IGS BR

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: Substance as such

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.2 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Exp. duration:

4 h

Mortality:

Male: 5.2 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.2 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Clinical signs of toxicity during exposure could not be visibly assessed due to the density of the test atmosphere and the fact that the rats were in nose-only restrainers. However, the normal response to an alerting response stimulus was determined duri

Body weight:

Female rats showed mainly slight (<9 g per day) to moderate (10 to 18 g per day) body weight losses over one to 3 days after exposure; male rats showed slight (<10 g per day) weight effects one day after exposure. These weight effects were followed by an essentially normal weight gain rate for the remainder of the recovery period in both sexes.

Gross pathology:

No gross lesions were present in the rats at necropsy.

Other findings:

One female rat had wet fur and a partially closed eye immediately after exposure; another female rat showed forelimb alopecia at the end of the recovery period.

The mean concentration of Terracess TF-S dust during the animal exposure was 5.2 ± 1.2 mg/L (mean ± S.D.). The mass median aerodynamic equivalent diameter, determined by cascade impactor measurement, was 3.0 μm with a geometric standard deviation of 1.6. The tested aerosol atmosphere was considered to be respirable in rats.

The chamber temperature during the animal exposure was 22 to 23°C, the relative humidity was 56 to 57%, the oxygen concentration was 20.9% and the airflow into the chamber was 24 L/min. These chamber environmental conditions were considered adequate for the conduct of the study.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for Terracess TF-S in male and female rats was greater than 5.2 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5.3 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 July 2004 to 5 January 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP in accordance with an internationally recognised test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

other: Ministry of Agriculture, Forestry, and Fisheries (MAFF) (1985). 59 NohSan Number 4200, Acute Dermal Toxicity. Testing Guidelines for Toxicity Studies

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:CD®(SD)IGS BR

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

other: Substance as such

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 5 cm x 7.4 cm
- Type of wrap if used: 2-ply gauze patch. then stretch gauze bandage and self-adhesive bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): equivalent to 5000 mg/kg bw
- For solids, paste formed: yes (with 0.7 ml of deionised water

Duration of exposure:

24 h

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin response

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: None

Gross pathology:

No gross lesions were present in the rats at necropsy

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the skin absorption LD50 for Terracess TF-L was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

Acute oral toxicity

In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice, a single dose of Terracess TF-L was administered by oral gavage to one fasted female rat each at a dose of 175 or 550 mg/kg and to three fasted female rats at a dose of 2000 mg/kg.

After 14 days of observations no deaths occurred, no clinical signs were observed, and no body weight loss occurred. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the oral LD50 for Terracess TF-L was greater than 2000 mg/kg for female rats.

Acute dermal toxicity

In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice a single dose of Terracess TF-L was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The application site was covered with a semi- occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application.

No deaths occurred during the study. Four rats exhibited no clinical signs during the study. Ocular and nasal discharge, and body weight loss, observed in some rats was not related to the test substance. No dermal irritation was observed. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the skin absorption LD50 for Terracess TF-L was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.

 

Acute inhalation toxicity

In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice one group of 5 male and 5 female rats was exposed nose-only to Terracess TF-S dust for a single, 4-hour exposure period. Rats were then observed for a 14-day recovery period. Rats were exposed to a mean chamber concentration of 5.2 mg/L of Terracess TF-S dust. The mass median aerodynamic diameter (MMAD) of the generated aerosol was 3.0 μm.

All rats exposed to Terracess TF-S survived the exposure and subsequent recovery period. Female rats showed mainly slight to moderate body weight losses over one to 3 days after exposure; male rats showed slight weight effects one day after exposure. These weight effects were followed by an essentially normal weight gain rate for the remainder of the recovery period in both sexes. Clinical observations were minimal and occurred in 2 female rats. Gross pathology examination revealed no evidence of organ-specific toxicity in any rats sacrificed at the end of the recovery period. Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for Terracess TF-S in male and female rats was greater than 5.2 mg/L.

Justification for selection of acute toxicity – oral endpoint

One available and valid study.  

Justification for selection of acute toxicity – inhalation endpoint

One available and valid study.  

Justification for selection of acute toxicity – dermal endpoint

One available and valid study.  

Justification for classification or non-classification

Based on the available studies, Terracess TF is not classified for acute toxicity according to Directive 67/548/EEC and CLP Regulation EC (No.) 1272/2008.