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Diss Factsheets

Administrative data

Description of key information

The acute oral as well as dermal LD50 of FAT 93460 were considered to be >2000 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:
07 July 2016 to 26 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Version / remarks:
EC 440/2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no
Specific details on test material used for the study:
Identification: FAT 93460/D
Batch: 20140721 (China)
Physical state/Appearance: yellow powder
Purity: 94.6 %
Expiry Date: 14 October 2019
Storage Conditions: approximately 4 °C in the dark
Species:
rat
Strain:
Wistar
Remarks:
RccHan™:WIST
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 159 - 173 g
- Fasting period before study: overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 July 2016 To: 26 July 2016
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted during the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
Executive summary:

A study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat according to OECD test guideline 420 in a GLP-certified laboratory. Following a sighting test at a dose level of 2000 mg/kg bw, additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.


 


Results:


Mortality: There were no deaths recorded.


Clinical Observations: There were no signs of systemic toxicity.


Body Weight: All animals showed expected gains in body weight.


Necropsy: No abnormalities were noted at necropsy.


Based on the findings of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw (Globally Harmonized Classification System - Unclassified).

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Test start date: 30 November 1995; Test end date: 14 December 1995; Study completion date: 26 February 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
92/69/EEC
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Identification: FAT 40543/A
Description: Red powder
Batch: TV RN 196-200
Purity: 90%
Test substance storage: At room temperature in the dark.
Stability under storage conditions: Stable
Expiry date: November 01, 2000
Stability in vehicle: 1% aqueous carboxy methyl cellulose.
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species: Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EEC).
Source: Charles River, Germany
Age at Start of Treatment: Approx. 8 weeks
Body weight at start of treatment: Within ± 20% of the sex mean
Number of animals: 5 males and 5 females
Identification: Ear mark

ANIMAL HUSBANDRY
Conditions : Air-conditioned room with approximately 15 air changes per hour and the environment controlled with optimal conditions considered as being a temperature of 21 °C and a relative humidity of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation: Individually housed in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands). Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet: Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium). Certificates of analysis were examined and then retained in the NOTOX archives.
Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1%
Details on dermal exposure:
TREATMENT
Method: Dermal application.
Shaving: One day before exposure (day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
Application: The test substance formulation was applied to an area of approximately 25 cm² (5x5 cm) for males and 18 cm² (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.), with drops of petrolatum.
Frequency: Once, on day 1.
Dose level: (volume) 2000 mg/kg (10 ml/kg) body weight.
Application period: 24 hours, thereafter dressings were removed and residual test substance removed using a tissue moistened with tap water.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw (single application)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
OBSERVATIONS
Mortality/Viability checks: Twice daily.
Body weight recordings: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of treatment (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded.
Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide asphyxiation and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
Statistics:
No statistical analysis was performed.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
No mortality occured during the study.
Clinical signs:
other: Signs of toxicity related to dose levels. Lethargy in all animals on day 1 was resolved by day 2.
Gross pathology:
Effects on organs: No treatment-related macroscopic findings were observed.
Other findings:
Signs of toxicity (local): Red staining of the skin, the treated area in particular, was observed in all animals and persisted in several animals throughout the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of FAT 40543/A is >2000 mg/kg bw.
Executive summary:

The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and EEC Directive 92/69/EEC, Part B.3, "Acute Toxicity - Dermal" to assess dermal toxicity of test substance on single application. A group of rats, containing 5 males and 5 females, was exposed to FAT 40543/A by dermal application at 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality was observed. Lethargy was observed in all animals at 4 hours after treatment and had resolved by day 2. Red staining of the skin, the treated area in particular, was observed in all animals and persisted in several animals throughout the observation period. Body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found in the animals at macroscopic post mortem examination. Based on the findings of the study, the dermal LD50 value of FAT40543/A in rats was established to be greater than 2000 mg/kg bw.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer chapter 13 for detailed read across justification.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of a read across substance FAT40543/A was found to be greater than 2000 mg/kg bw; no mortality was observed at the dose of 2000 mg/kg bw.
Executive summary:

Currently, no study assessing the acute dermal toxicity of FAT 93460 is available. However, the source substance FAT 4053/A was assessed in a study that was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and EEC Directive 92/69/EEC, Part B.3, "Acute Toxicity - Dermal". A group of rats, containing 5 males and 5 females, was exposed to FAT 40543/A by dermal application at 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality was observed. Lethargy was observed in all animals at 4 hours after treatment and had resolved by day 2. Red staining of the skin, the treated area in particular, was observed in all animals and persisted in several animals throughout the observation period. Body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found in the animals at macroscopic post mortem examination. Based on the findings of the study, the dermal LD50 value of FAT40543/A in rats was established 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 GLP study

Additional information

Acute toxicity: oral

The acute oral toxicity potential of the test item was assessed in a fixed dose prcedure study conducted with the Wistar strain rats. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. Hence, based on the findings of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

 

Acute toxicity: inhalation

Currently no study for assessment of acute inhalation toxicity of Disperse Yellow 114 is available. However, it was estimated to have low vapour pressure (<0.5 KPa), so the potential for the generation of inhalable forms is low. 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. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is unlikely. Further in the case, the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral toxicity study with no mortality or systemic toxicity up to 2000 mg/kg bw, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Disperse Yellow 114 via inhalation route. Hence, safety for human health can be estimated via route to route extrapolation and testing by the inhalation route was considered scientifically not necessary.

 

Acute toxicity: dermal 

Currently no study to assess acute dermal toxicity of Disperse Yellow 114 is available. However, the molecular weight of the chemical is 424.43 g/mol g/mol, indicating limited dermal absorption. The substance has low solubility in water (0.7 µg/L), hence dermal uptake is likely to be low as the substance is considered as not sufficiently soluble in water to partition from the stratum corneum into the epidermis. Further, no adverse effects were observed in acute oral studies (LD50 >2000 mg/kg) suggesting that the substance has low toxicity, hence, it does not need to be classified as STOT SE. Further, no significant toxicity is expected via dermal route and safety for human health can be estimated via route to route extrapolation. Similarly, absence of systemic toxicity or mortality in skin irritation and sensitization studies, supports the conclusion that no adverse effects are expected via 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 considered.

In addition, data available for the read-across substance Disperse Yellow 246 (FAT 40543/A) are available. The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and EEC Directive 92/69/EEC, Part B.3, "Acute Toxicity - Dermal". FAT 40543/A was administered to five rats of each sex by dermal application at 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Lethargy was observed in all animals at 4 hours after treatment and had resolved by day 2. Red staining of the skin, the treated area in particular, was observed in all animals and persisted in several animals throughout the observation period. Body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found in the animals at macroscopic post mortem examination. Hence, the dermal LD50 value of FAT 40543/A in rats was established as exceeding 2000 mg/kg bw.

In addition, these data support the initial consideration for Disperse Yellow 114 not to harvest any acute dermal toxicity. Therefore, no further testing is considered.

Justification for classification or non-classification

Based on the available data on acute toxicity, FAT 93460 does not warrant the classification based on CLP (Regulation No. 1272/2008) criteria.