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Description of key information

The test substance is not toxic in an acute oral, inhalation and dermal toxicity studies.

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:
3 February 1994 to 6 April 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: November, 1998
- Test article:: FAT 40066/C

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 200 to 246 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding \
- Diet: rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)) ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
Administration of the test arrticle: one single oral dose, by gastric intubation (gavage)
Volume applied: 10 ml/kg body weight
Doses:
2000 mg/kg (males and females)
No. of animals per sex per dose:
10 animals
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred in this study.
Clinical signs:
Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 1 to 2 days.
Body weight:
None
Gross pathology:
At necropsy, no deviations from normal morphology were found in all animals.
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of FAT 40066/C in rats is greater than 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 40066/C was investigated in an an OECD 401 guideline test according to GLP. The test substance was investigated on 10 rats in total. A single dose of 2000 mg/kg bw orally was tested according to OECD guideline 401 and EU method B.1. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy was performed. Piloerection, hunched posture and dyspnoea were seen, being common symptoms in acute tests but the animals recovered within 1 to 2 days. At necropsy, no deviations from normal morphology were found in all animals. In conclusion, the acute oral LD50 of FAT 40066/C in rats of both sexes observed over a period of 14 days is 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:
OECD guideline and GLP compliant study.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 June 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
traditional method
Limit test:
no
Specific details on test material used for the study:
Lanasol Red 6G, Product No. 01-146394-100-0, Batch No. (DCT No. 8-0053) 78316/11
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 247 and 345 g
- Fasting period before study: 1 hour
- Housing: housed, individually, in suspended, wire bottom cages
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 74 ± 1
- Humidity (%): 45 to 55
- Photoperiod (hrs dark / hrs light): 12 hours
Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Remark on MMAD/GSD:
None
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 3-neck, round-bottom, 250 ml Pyrex flask
- Source and rate of air: 0.5 liter of air per minute per rat.

Duration of exposure:
4 h
Remarks on duration:
None
Concentrations:
The average analytical concentration obtained was 0.42 ± 0.32 mg/L.
No. of animals per sex per dose:
None
Control animals:
not specified
Details on study design:
None
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.42 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions
Mortality:
No mortality observed.
Clinical signs:
other: Abnormal exposure at 3 to 4 h of exposure and upto 4 h post exposure in all animals. No abnormalities were noted during the 14-day post-exposure period.
Body weight:
No effects observed.
Gross pathology:
Gross pathological observations showed organs of all animals to be within normal limits.
Other findings:
No effects observed

The average mass median diameter of particles for the 4-hour exposure was 3.90 ± 0.44 µm. Abnormal respiration was noted during the last 2 hours of the 4-hour exposure for all animals. This condition persisted for the first 4 hours post-exposure; however, all animals appeared to be normal for the remainder of the post-exposure period. Abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals.

Interpretation of results:
GHS criteria not met
Conclusions:
The LC50 of test substance was 0.42 ± 0.32 mg/l and was found to be non toxic via inhalation.
Executive summary:

An acute toxicity study via inhalation was performed in 10 laboratory rats (5 males & 5 females) initially weighing between 247 and 345 grams, for 4 hours via the inhalation route at an atmospheric concentration of 0.42 ± 0.32 mg/l, exhibited abnormal respiration for the last half of the exposure. This condition persisted for approximately 4 hours post-exposure. The test substance was generated as a dust using a 3-neck, round-bottom, 250 ml Pyrex flask. No abnormalities were noted during the 14-day post-exposure period. There was no mortality seen. No abnormalities were noted during the 14-day post-exposure period except abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals which was subsided from Day1 of observation period. Gross pathological observations showed organs of all animals to be within normal limits. The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions. The average mass median particle diameter was 3.90 ± 0.44 µm. Gross pathological observations showed organs of all animals to be within normal limits. Based on the study results the LC50 of test substance (FAT 40066) was 0.42 ± 0.32 mg/l.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
klimisch score 2

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 May 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
None
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
'Lanasol Red 6G, Product #01- 146394- 100-0, Batch No. 78316/11 (DCT No. 8-0053), brownish-red powder
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, Pennsylvania
- Weight at study initiation: 2.3 and 3.0 kgs
- Diet: ad libitum
- Water: ad libitum

Type of coverage:
occlusive
Vehicle:
water
Remarks:
warm
Details on dermal exposure:
24 hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper exposing approximately 30 % of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. The animals were then returned to their individual cages and observed for toxic signs and survival.
Duration of exposure:
24 hours
Doses:
3 gm/kg of body weight
No. of animals per sex per dose:
6 animals per dose
Control animals:
not specified
Preliminary study:
None
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
There were no adverse clinical signs observed in any of the six animals throughout the study.
There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study.
Body weight:
All animals displayed an acceptably consistent weight pattern over the 14 days
Gross pathology:
Necropsies revealed all organs to be within normal limits
Interpretation of results:
GHS criteria not met
Conclusions:
Acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.
Executive summary:

A acute toxicity study via dermal route was performed on New Zealand albino. The test material was applied, in the quantity of 3000 mg/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. Six animals were used in the study. There were no mortality observed. There were no adverse clinical signs observed in any of the six animals throughout the study. There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study. All gross necropsies were within limits. Based on the findings, an acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw
Quality of whole database:
klimisch score 2

Additional information

Acute Oral Toxicity:


The acute oral toxicity of FAT 40066/C was investigated in an an OECD 401 guideline test according to GLP. The test substance was investigated on 10 rats in total. A single dose of 2000 mg/kg bw orally was tested according to OECD guideline 401 and EU method B.1. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy was performed. Piloerection, hunched posture and dyspnoea were seen, being common symptoms in acute tests but the animals recovered within 1 to 2 days. At necropsy, no deviations from normal morphology were found in all animals. In conclusion, the acute oral LD50 of FAT 40066/C in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw. In another study, an acute oral toxicity study with FAT 40066/A was carried out in Tif RAI male and female rats (5/sex/dosage) at the dose concentration of 4640, 6000 and 7750 mg/kg. A 30 % concentration as formulation was used. All animals were observed for mortality, clinical signs, body weight and gross pathology. One female animal each on day 7 and day 14 died from the 7750 mg/kg dose group. All animals from 4640 and 6000 mg/kg dose group survived. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 8 to 11. days. No substance related gross organ changes were seen. Based on the study results, the acute oral median lethal dose (LD50) of FAT 40066/A in rats of both sexes observed, over a period of 14 days is greater than 7700 mg/kg.


Acute Inhalation Toxicity:


An acute toxicity study via inhalation was performed in 10 laboratory rats (5 males & 5 females) initially weighing between 247 and 345 grams, for 4 hours via the inhalation route at an atmospheric concentration of 0.42 +/- 0.32 mg/l, exhibited abnormal respiration for the last half of the exposure. This condition persisted for approximately 4 hours post-exposure. The test substance was generated as a dust using a 3-neck, round-bottom, 250 ml Pyrex flask. There was no mortality observed. No abnormalities were noted during the 14-day post-exposure period except abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals which was subsided from Day1 of observation period. Gross pathological observations showed organs of all animals to be within normal limits. The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions. The average mass median particle diameter was 3.90±0.44µm. Based on the study results the LC50 of test substance was 0.42 ± 0.32 mg/l.


 


Acute Dermal Toxicity:


An acute toxicity study via dermal route was performed on New Zealand albino rabbits as per the method which is equivalent of OECD guideline 402. The test material was applied, in the quantity of 3000 mg/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. Six animals were used in the study. There was no mortality observed. There were no adverse clinical signs observed in any of the six animals throughout the study. There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study. All gross necropsies were within limits. Based on the findings, an acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.

Justification for classification or non-classification

Based on the acute oral, inhalation and dermal toxicity studies, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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