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Administrative data

Description of key information

Acute toxicity via oral route:

oral  LD50 rat > 10000 mg/kg bw (standardized test protocol; BASF 1978)

Acute toxicity via inhalation route:

Not relevant

Acute toxicity via dermal route:

No mortality or systemic toxicity was observed in a 7-h inhalation hazard test (IHT, BASF, 1978) and in a 5-d bioavailability study (BASF, 33I0110/91008, 1994; see section 7.5.2).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
BASF test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 10 animals/sex was treated by single gavage with an aqueous suspension of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior to treatment only. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: 16 h
- Housing: Makrolon Typ III (maximum 5 animals per cage)
- Diet: standard pellet diet for mice and rats, ad libitum
- Water: ad libitum
- Acclimation period: 3-7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): 55+/-10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5%

MAXIMUM DOSE VOLUME APPLIED: 31.6 mL/kg
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed within the first 15 min after application and 30 min, 1 h, 2 h, 4 h, 5 h, 24 h after application; subsequently at least once daily. Animals were weighed directly before the application.
- Necropsy of survivors performed: yes
Statistics:
not performed
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 10 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Nothing abnormal observed.
Body weight:
Normal weight gain.
Gross pathology:
Nothing abnormal observed.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
10 000 mg/kg bw
Quality of whole database:
Guideline compliant study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity via oral route:

Key study:

For the oral exposure pathway a limit test is available, performed according to a standardized internal method, which is in principle comparable to the OECD guideline 401, but for which GLP compliance was not confirmed (BASF 1978). Since there were no mortalities, clinical signs or necropsy findings observed in male and female rats dosed with 10000 mg/kg bw after the 14 d observation period, the acute oral LD50 is > 10000 mg/kg bw and the LD0 is ≥ 10000 mg/kg bw in rats.

Supporting studies:

The result of the key study is supported by two supporting studies, which reveled an LD50 >5000 mg/kg and >10000 mg/kg (Ishihara Sangyo Kaisha 1985; Bayer 1972).

Acute toxicity via dermal route:

No data were available for acute dermal toxicity. In accordance with Regulation (EC) 1907/2006 (REACH), the acute dermal route was waived as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 >2000 mg/kg, see section 7.2.1). Additionally, no systemic effects have been observed in the in vivo studies with dermal exposure (see section 7.3.1).

Acute toxicity via inhaltion route:

For the acute inhalation via the inhalation route two studies were considered in a weight of evidence approach. An acute inhalation hazard test (IHT), performed in principle as described in the OECD Guideline 403, is available (BASF, 1978). In this study, rats were exposed for a period of 7 hours to an atmosphere saturated with vapors of the volatile components of the test substance at 20 °C. No mortality was observed during this test.

Additionally, a valid subacute inhalation study was performed in rats only with an analogous substance, the nickel rutile. In a GLP compliant bioavailability study, male Wistar rats were exposed for 5 d to 60 mg/m³ of the test substance; the observation period was 0, 3, 10, 31 and 60 d (BASF, 33I0110/91008, 1994). No effects on mortality, clinical signs, body weights and body weight gains were found. Clearance half time was approximately 50 d in the lung. The study was not able to demonstrate bioavailability after inhalation of the test substance.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on the available toxicity data and the physical-chemical properties of the test substance, it is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EC) No 2016/1179.