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Administrative data

Description of key information

FAT 20036 is found to have acute oral LD50 >5000 mg/kg bw.

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:
From 14 April 1994 to 28 April 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, B.l. "Acute Toxicity-Oral", July 31, 1992
Deviations:
yes
Remarks:
The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
Qualifier:
according to guideline
Guideline:
other: U. S. Environmental Protection Agency, Code of Federal Regulations 40, Part 798, Health Effects Testing Guidelines, Subpart B - General Toxicity Testing, Section 798.1175 "Acute Oral Toxicity"; Revised as of July 01, 1992
Deviations:
yes
Remarks:
The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
Qualifier:
according to guideline
Guideline:
other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).
Deviations:
yes
Remarks:
The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Identification : IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F)
Description : Lumpy black powder
Batch number : 1
Identification : 097911-1
CAS·Nr : 075314-27-1
Purity: ca 97.7%
Expiry date: July 1999
Storage conditions: In the original container at room temperature away from direct sunlight.
Species:
rat
Strain:
other: Rat, Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland.
- Weight at study initiation for males: 197.6 - 213.4 g.
- Weight at study initiation for females: 177.6 - 188.5 g.
- Age at study initiation: 8 for males and 10 for females
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Randomozation: Randomly selected at the time of delivery into groups of five.
- Acclimatization: One week under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.

Conditions:
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour, a continuously monitored environment with a temperature of 22 ± 2 °C, a relative humidity between 36-58%, 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

Accommodation:
Groups of five in Makrolon type-4 cages (size: 33 x 55 x 20 cm) with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).

Diet:
Pelleted standard Kliba 343, Batch no.73/94 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application).

Water:
Community tap water from Füllinsdorf, available ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Bidistilled water
Details on oral exposure:
VEHICLE: Bidistilled water

TREATMENT:
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for 16 to 22 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.

MAXIMUM DOSE VOLUME given: 10 ml/kg body-weight
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Mortality: Four times during test day 1 and daily during days 2-15.
- Frequency of observations and weighing: On test day 1 (pre-administration), 8 and 15.
- Clinical signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded
- Necropsy of survivors performed: Necropsies were performed by experienced prosectors. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight and sacrificed by exsanguination. The animals were examined macroscopically.
Statistics:
The LOGIT- Model could not be used as no deaths occurred.
Preliminary study:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No moratlity was observed.
Clinical signs:
No clinical signs of toxicity were observed during the observation period.
Body weight:
The rate of body weight gain of the animals during the observation period was not affected by treatment with the test article.
Gross pathology:
No organ abnormalities were observed at necropsy.
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of FAT-20036/F in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw.
Executive summary:

The test article IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was tested for acute oral toxicity according to OECD Guideline 401. FAT 20036/F was administered to a group of 5 male and 5 female rats by oral gavage, at the single maximal dose of 2000 mg test article/kg bw.

There were no deaths observed as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy.

Based on the above findings, the mean lethal dose (LD50) of IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was found to be greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality study

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

Several studies investigating acute toxicity of FAT 20036 via oral route are available.

In the study (1994) designated to be key, the test article IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was tested for acute oral toxicity according to OECD Guideline 401. FAT 20036/F was administered to a group of 5 male and 5 female rats by oral gavage, at the single maximal dose of 2000 mg test article/kg bw. There were no deaths observed as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy. Based on the above findings, the mean lethal dose (LD50) of IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was found to be greater than 2000 mg/kg bw.

Four others supporting studies are available where FAT 20036 was investigated over a dose range of 1000 to 20000 mg/kg bw. In these studies, no mortality was reported even at 5000 mg/kg bw. Hence, FAT 20036 can be assumed to have low acute toxicity via oral route.

Inhalation:

Currently no study to assess the acute inhalation toxicity potential of FAT 20036 is available. However, the vapour pressure for the target chemical is considered to be low owing to the high melting point (>350 °C), hence its considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further the chemical was found to have low acute toxicity when tested via oral route with no mortality and clinical signs when tested at 5000 mg/kg bw. Hence, considering all the above arguments, it is considered that FAT 20036 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.

Dermal:

Currently no study to assess acute dermal toxicity of FAT 20036 is available. The partition coefficient (n-octanol/water) of the chemical was determined to be -0.70, while the water solubility was 53.7 g/l. These physicochemical properties indicate chemical istoo hydrophilic to cross the lipid rich environment of the stratum corneum, supporting the hypothesis that dermal uptake for the chemical will be low. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50 >5000 mg/kg bw), with neither mortality nor clinical sings being seen. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected via the dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic administration. Hence, low toxicity is expected on acute dermal exposure of FAT 20036 and testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

FAT 20036 is found to have low acute toxicity via oral route with LD50 >5000 mg/kg bw. Hence, it does not meet the criteria for classification according to the Regulation (EC) No. 1272/2008.