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Administrative data

Description of key information

The acute oral LD50 of FAT 20063 in rats was determined to be >10000 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:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Methodology comparable to internationally accepted guidelines
GLP compliance:
no
Remarks:
Study was conducted prior to GLP and OECD guideline implementation.
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
None
Species:
rat
Strain:
other: Tif. RAI rats
Sex:
male/female
Details on test animals and environmental conditions:
The compound was tested on 30 Tif. RAI rats (15 males/15 females), bred under SPF conditions in our own breeding unit. They were 6 to 7 weeks old and weighed 160 to 180 g. The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 ± 1 °C and a relative humidity of approximately 50 %. They received water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved during one night before starting the treatment.
Route of administration:
oral: gavage
Details on oral exposure:
No data.
Doses:
4640 mg/kg bw (40% formulation), 6000 mg/kg bw (40 % formulation), 10000 mg/kg bw (50 % formulation)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
FAT 20063/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 40 and 50 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Dose levels used: 4640, 6000 qnd 10000 mg/kg. No other high dose was possible.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. Additionally in the highest dosage group, diarrhoea was observed. All animals had recovered within 9 days. They were killed and autopsied after an observation period of 14 days.
Body weight:
Not specified
Gross pathology:
No substance related gross organ changes were seen.

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of FAT 20063/A in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw (based on test material).
Executive summary:

Acute oral toxicity of the test substance was evaluated in a study conducted according to a methodology equivalent to OECD Guideline 401. Three groups each consisting of 5 males and 5 females were administered the test substance through oral route at the doses of 4640, 6000 and 10000 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. Additionally in the highest dosage group, diarrhoea was observed. All animals had recovered within 9 days. No mortality was seen throughout the observation period. They were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Hence, based on the findings of the study, it can be concluded that the acute oral LD50 of FAT 20063/A in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
10 000 mg/kg bw
Quality of whole database:
Good quality study with a methodology equivalent to OECD Guideline 401

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 oral:

Two acute oral toxicity studies with the test substance are available for the assessment.

In a key study, a limit test was conducted according to the methodology equivalent to OECD Guideline 401. 5 male and 5 female rats received the test item at the single dose of 5000 mg/kg bw by oral intubation. Observations of mortality and clinical signs were carried out after 1, 2, 3, 5 and 24 hrs of dosing, and daily thereafter for 14 days; while weighing was done on days 1, 7 and 14. The surviving rats were subjected to necropsy at the end of observation period. No mortality was observed through the duration of the study. Clinical signs like sedation, dyspnoea, ruffled furs, diarrhoea, and curved body position were observed. The animals recovered within 8 days. No effect on body weight gains was seen. No substance related gross organ changes were seen during the gross pathological examination. Hence, based on the above findings, the test substance was determined to have a LD50 of >5000 mg/kg bw.

In a supporting study, acute oral toxicity of the test substance was evaluated according to the methodology equivalent to OECD Guideline 401. Three groups each consisting of 5 males and 5 females were administered the test substance through oral route at the doses of 4640, 6000 and 10000 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. Additionally in the highest dosage group, diarrhoea was observed. All animals had recovered within 9 days. No mortality was seen throughout the observation period. They were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Hence, based on the findings of the study, it can be concluded that the acute oral LD50 of FAT 20063/A in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw.

Based on the findings of the study, it can be concluded that target substance has low toxicity potential when adminstered via oral route.

Acute inhalation:

Currently no study to assess the acute inhalation toxicity potential of Acid Blue 185 is available. However, the vapour pressure forthe substance is considered to be low owing to the high melting point (>350 °C). Hence the substance is considered to have low volatility. The low partition coefficient of <-5.9 at 20 °C, again point to poor absorption across the respiratory tract.Acid Blue 185 was found to have high water solubility (485.2 g/L), hencethe inhaled dust may be retained within the mucus of the respiratory tract, thereby limiting the absorption. 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, no systemic effects were observed in the acute oral toxicity study with FAT 92348/B. Owing to the high water solubility, absorption through gastro-intestinal tract through oral ingestion is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity, acute inhalation exposure is considered to have negligible potential for systemic toxicity. Therefore testing by the inhalation route was considered scientifically not necessary and the intrinsic property/toxicity potential can be extrapolated from the acute oral route administration.

Acute Dermal:

Currently no study to assess acute dermal toxicity of Acid blue 185 is available. However, the molecular weight of the substance is 879.0 g/mol, which indicates substance is too large for dermal absorption. Further, high water solubility (485.2 g/L) and low partition coefficient (<-5.9 at 20 °C), indicate the substance may be too hydrophilic to cross the lipid rich environment of thestratum corneum. Hence, the dermal uptake for the substance is expected to be low. Further, no systemic effects were observed in the acute oral toxicity study with FAT 92348/B. Owing to the high water solubility, absorption through gastro-intestinal tract through oral ingestion is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity, acute dermal exposure is considered to have negligible potential for systemic toxicity. Therefore testing by the inhalation route was considered scientifically not necessary and the intrinsic property/toxicity potential can be extrapolated from the acute oral route administration.

Justification for classification or non-classification

Based on the results of the available acute oral toxicity studies, the substance does not warrant classification for acute toxicity according to CLP (Regulation 1272/2008) criteria.