RAL 3.0

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Regarding the oral route, no mortality was observed within an observation period of 14 days in a limit test according to OECD guideline 401 using 5 female and 5 male Sprague Dawley rats.

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Regarding the oral route, no mortality was observed within an observation period of 14 days in a limit test according to OECD guideline 401 using 5 female and 5 male Sprague Dawley rats.

Adequacy of study:

weight of evidence

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Label: CRIOLITE SINTETICA
Description: white powder
Batch No.: 11

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Starin: Cr1:CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males 225-250 g, females 200 - 225 g
- Housing: 5 animals/sex/cage in air-conditioned rooms
- Diet (e.g. ad libitum): GLP 4RF21 pelleted diet ad libitum
- Water (e.g. ad libitum): from the municipal water main system ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hours

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

deionized water, administrationvolume 20 ml/kg

Doses:

5000 mg/kg bw

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: at 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, clinical signs and mortality
(since no changes were found at necropsy, histological examination was not performed)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed on animals treated at 5000 mg/kg bw (limit dose) during the post-treatment observation period

Clinical signs:

Some of the animals showed piloerection starting 6 hours after administration. This sign lasted up to day 5. One male rat showed diarrhea, with short duration, at the 6 hour observation. All animals achieved recovery within day 6.

Body weight:

The body weight gain of all the treated animals was considered within the normal limits for rats of this strain and age.

Gross pathology:

No appreciable macroscopic findings were observed.

Interpretation of results:

GHS criteria not met

Remarks:

In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for acute oral toxicity based on the available data.

Conclusions:

The only hazardous component of RAL 3.0 is trisodium hexafluoroaluminate. It is present in amounts less than 1%. Because of this the preparation is not harmful.
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.

Executive summary:

LD50 exceeding 5000 mg/kg bw

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

impurity

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature

Specific details on test material used for the study:

Label: CRIOLITE SINTETICA
Description: white powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Starin: Cr1:CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males 225-250 g, females 200 - 225 g
- Housing: 5 animals/sex/cage in air-conditioned rooms
- Diet (e.g. ad libitum): GLP 4RF21 pelleted diet ad libitum
- Water (e.g. ad libitum): from the municipal water main system ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized water, administrationvolume 20 ml/kg

Doses:

5000 mg/kg bw

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: at 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, clinical signs and mortality
(since no changes were found at necropsy, histological examination was not performed)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed on animals treated at 5000 mg/kg bw (limit dose) during the post-treatment observation period.

Clinical signs:

Some of the animals showed piloerection starting 6 hours after administration. This sign lasted up to day 5. One male rat showed diarrhea, with short duration, at the 6 hour observation. All animals achieved recovery within day 6

Body weight:

The body weight gain of all the treated animals was considered within the normal limits for rats of this strain and age.

Gross pathology:

No appreciable macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for acute oral toxicity based on the available data.

Conclusions:

The only hazardous component of RAL 3.0 is trisodium hexafluoroaluminate. It is present in amounts less than 1%. Because of this the preparation is not harmful.
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.

Executive summary:

LD50 exceeding 5000 mg/kg bw