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Description of key information

FAT 36002 is determined to have an acute oral LD50 of >5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See Chapter 13 for detailed read across justification.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986
Species:
rat
Strain:
other: Tif: RAIf (SPF) hybrids of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
Experimental Animals
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 180 to 231 g
Initial Age: 7-8 weeks
Individual Identification: by colour code using picric acid

Husbandry:
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
The animal room was air conditioned: temperature 22+_3° C, relative humidity 55+_15%, 12 hours light/day, approximately 15 air changes/h.

Diet:
Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum

Acclimatisation:
at least 5 days before administration
Route of administration:
oral: gavage
Vehicle:
water
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: clinicals signs-daily, mortality check- daily twice, body weights weekly
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed throughout the observation period.
Clinical signs:
Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration.
The animals recovered within 12 days.
Body weight:
No adverse effects on body weight changes was observed.
Gross pathology:
No gross abnormalities were found.

None

Conclusions:
FAT 40284/A was determined to have a LD50 of >5000 mg/kg bw.
Executive summary:

The acute oral toxicity of the read across substance was evaluated in a study conducted according to OECD Guideline 401. A single group consisting 5 males and 5 females was administered a dose of 5000 mg/kg bw once and observed over a period of 14 days for clinical signs, mortality an body weight changes. The surviving animals were sacrificed and necropsies were conducted at the end of the observation period. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration. The animals recovered within 12 days. No mortality and no adverse effect on body weights were seen. No gross abnormalities were found during the necropsy. Hence, LD50 for FAT 40284/A was determined to be > 5000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Setacyl Blue P-RBLD, Pkg. //1 30-I 31-790 Standard
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Details on oral exposure:
Investigational Procedures
Young albino rats of the Sprague-Dawley strain ranging in body weight from 150 to 227 grams were used as test animals. All animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals. The animals were housed in stock cages and permitted a standard laboratory diet plus water ad libitum, except during a 16-hour period immediately prior to oral intubation when food was withheld. Initial screening was conducted in order to determine the general level of toxicity of each of the fifteen samples. Selected groups of four r a t s each (two males and two females) were then intubated with the respective sample at several selected dose levels. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle. Following oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages and observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days. At the end of the observation period, the acute oral median lethal dose (LD50) of each test material was calculated using the techniques of Weil*, Thompson**, and Thompson and Weil***

*Weil, Carrol S. : Tables for Convenient Calculation of Median - Effective Dose (LD50 or ED50) and Instruction's in Their Use. Biometrics, Sept. 19 52.
**Thompson, William R. : Use. of Moving Averages and Interpolation to Estimate Median-Effective Dose. Bact. Rev. , Nov. 1947.
***Thompson, William R. and Weil, Carrol S.: On the Construction of Tables for Moving Average Interpolation. Biometrics, March 19
Doses:
4.6, 6.8, 10.2, 15.4 g/kg bw
No. of animals per sex per dose:
2 males, 2 females
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
11 300 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 650 mg/kg bw
Based on:
act. ingr.
Mortality:
4.6 g/kg bw dosing group: 0/4
6.8 g/kg bw dosing group: 0/4
10.2 g/kg bw dosing group: 1/4
15.4 g/kg bw dosing group: 4/4

Dose (g/kg) Reaction          Time of Onset  Duration of Reaction  Time of Death Following Dose Administration

4.6         Hypoactivity      1 hour         2 days                 -

            Ruffed fur         6-22 hours     1 day                 -

6.8         Hypoactivity      1 hour         2 days

            Ruffed fur         1 hour         2 days

            Muscular weakness 6-22 hours     1 day

10.2        Hypoactivity      1 hour         3 days                 6-22 hours

            Ruffed fur        1 hour         3 days

            Muscular weakness 5 hous         2 days

            Diarrhea          6-22 hours     1 day

15.4        Hypoactivity      1 hour         until death           6-22 hours

            Ruffed fur        1 hour

            Muscular weakness 5 hous

            Diarrhea          5 hous

            Prostration       5 hous

Acute Oral LD50: 11.3 g/kg.

Standard Deviation of LD50 +/- 1.2 g/kg.

* The test material was administered as a 50.0 percent (w/v) aqueous suspension. Doses are expressed in terms of Setacyl Blue P-RBLD.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Guideline 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: oral

The acute oral toxicty of the test material was tested in an acute toxity study on the product in 1071. The test material was applied at 4 different doses to 2 male and 2 female rats each. Animals have been observed for a certain time (not reported in details, at least 3 days) following administration and clinical signs as well as deaths have been recorded and reported. The LD50 was calculated to >5000 mg based on the acitve ingredient and to 11.3 g/kg bw, based on the test material.

In addition, the acute oral toxicity of the read across substance was evaluated in a study conducted according to OECD Guideline 401. A single group consisting 5 males and 5 females was administered a dose of 5000 mg/kg bw once and observed over a period of 14 days for clinical signs, mortality an body weight changes. The surviving animals were sacrificed and necropsies were conducted at the end of the observation period. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration. The animals recovered within 12 days. No mortality and no adverse effect on body weights were seen. No gross abnormalities were found during the necropsy. Hence, LD50 for FAT 40284/A was determined to be > 5000 mg/kg bw.

 

Acute toxicity: inhalation

Currently no study to assess the acute inhalation toxicity of FAT 36002 is available. However, as the melting point >350 °C indicates low volatility, the substance may not be available for inhalation as a vapour. Further, the high values of the acute oral toxicity studies (LD50 >5000 mg/kg bw), indicate no adverse effects are expected via the inhalation route. Further, production and spray drying is performed in closed processes without isolation of reaction products. Isolated product is present in dust free granules (non-dusty solid). Therefore the study will be waived and the intrinsic property/toxicity potential will be extrapolated from the acute oral toxicity study. Experience with similar chemical structures demonstrated that it is very unlikely that toxicity related to intrinsic properties of the test item only show upviathe inhalation route and notviathe oral-gastric route of exposure. Further, production and spray drying is performed in closed processes without isolation of reaction products. Isolated product is present in dust free granules (non-dusty solid). Therefore the study will be waived and the intrinsic property/toxicity potential can be extrapolated from the acute oral toxicity study. 

Acute toxicity: dermal

Currently no study to assess acute dermal toxicity ofDisperse Blue 056is available.However, it has very low solubility in water (<0.1 mg/L), hence dermal uptake is likely to be low as the substance is considered as not sufficiently soluble in water to partition from thestratum corneuminto the epidermis. The absence of toxicologically significant adverse effects in the acute oral toxicity studies (LD50>5000 mg/kg bw), indicate Disperse Blue 056 to have very low acute toxicity. Similarly absence of systemic toxicity or mortality in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expectedviathe dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the test item only show up upon dermal exposure and not after systemic application, hence further experiments to assess dermal toxicity are not taken into account and the intrinsic property/toxicity potential can be extrapolated from the acute oral toxicity study. 

Justification for classification or non-classification

Based on ther available data, FAT 36002 does not warrant calssification according to the CLP Regulation (EC n. 1272/2008).