JAUNE REACTIF 181

Endpoint summary

Description of key information

Acute oral toxicity:

In a GLP-compliant oral toxicity study, performed according to OECD guideline 401, Wistar rats (5/sex/dose) were administered FAT 40400/A at dose of 2000 or 5000 mg/kg bw by oral gavage followed by a 14-day observation period. All animals survived. Only diarrhea was observed in the highest dose group during day one of the observation period. No macroscopical changes were observed. There were no effects on body weights. Based on the observations, the acute oral median lethal dose (LD50) of FAT 40400/Ain rats of both sexes observed for a period of 14 days was greater than 5000 mg/kg bw.

 

Acute inhalation toxicity:

Currently no study to assess acute inhalation toxicity of Reactive Yellow 181 is available. However, low vapour pressure owing to high melting point (>300 °C), the substance is considered to have low volatility. Synthesis and formulation of this chemical is performed in a closed process; the final product consists of liquid formulation only. 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 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 liquid formulation, the exposure via inhalation is unlikely. Further, Reactive Yellow 181 was found to be miscible in water (water solubility 332 g/L) and have low log partition coefficient (-10), hence, in the case of dust of 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 (LD₅₀>5000 mg/kg bw) and acute dermal (LD₅₀>2000 mg/kg bw) with no mortality or systemic toxicity, hence, it does not need to be classified as STOT SE. Taking the above arguments into consideration, low toxicity potential is expected on acute exposure of Reactive Yellow 181 via inhalation route.

 

Acute dermal toxicity:

In a GLP-compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered FAT 40400/A at the dose of 2000 mg/kg bw. The test substance was dissolved in water and applied on the skin with a syringe and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Scales and discoloration were observed until termination of the study. No macroscopic findings were noted. Therefore, the acute dermal median lethal dose (LD50) of FAT 40400/A was estimated 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:

06 April 1990 to17 May 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the original container, at room temperature,
protected from light
- Stability under storage conditions: stable
- Stability of the test substance in the solvent/dispersant/vehicle/test medium: stable for at least 2 hours

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females, 11 weeks
- Weight at study initiation: males: 206 - 230 g, females: 175 - 195 g
- Fasting period before study: 12-18 hours
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: Pelleted standard Kliba 343, Batches 67/90 and 68/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst, available ad libitum
- Water: Community water from Itingen, available ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw at 2000mg/kg group, 20mL/kg bw at 5000mg/kg bw group

Doses:

2000 or 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: Mortality / Viability: Four times during test day 1, and daily during days 2-15, Body Weights: Test days 1 (pre-administration), 8 and 15, Symptoms: Each animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (general behaviour, respiration, eye, nose, motility, body posture, motor susceptibility, skin), gross pathology

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0 % at 2000 mg/kg bw
0 % at 5000 mg/kg bw

Clinical signs:

other: 2000 mg/kg: no clinical signs observed 5000 mg/kg: diarrhea (only observed at the first day of observation)

Gross pathology:

No macroscopical findings were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 40400/A in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg bw.

Executive summary:

In a GLP-compliant oral toxicity study, performed according to OECD guideline 401, Wistar rats (5/sex/dose) were administered FAT 40400/A at dose of 2000 or 5000 mg/kg bw by oral gavage followed by a 14-day observation period. All animals survived. Only diarrhea was observed in the highest dose group during day one of the observation period. No macroscopical changes were observed. There were no effects on body weights. Based on the observations, the acute oral median lethal dose (LD50) of FAT 40400/A in rats of both sexes observed for a period of 14 days was greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

GLP-compliant guideline study, Klimisch code 1

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

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 April 1990 to 19 April 1990

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))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Identification Code: FAT 40400/A
Batch No.: BG 3247/TV6
Appearance: red solid
Purity: 84 %
Solubility (in water): a.100 g/l
Storage: room temperature
Stability: 03/95

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females, 11 weeks
- Weight at study initiation: males: 218 - 243 g, females: 194 - 206 g
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batches 67/90 and 68/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst, available ad libitum
- Water: Community water from Itingen, available ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1, 4 mL at 2000 mg/kg test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water and dried with disposable paper towels and the skin reaction was assessed.

Duration of exposure:

24 hours

Doses:

2000 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
- Mortality/viability were measured four times during test day 1 (pre-administration) and daily during days 2 - 15.
- Body weights were measured on day 1, 8 and 15.
- All animals were necropsied.
- Each animal had an examination for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded.

Statistics:

The LOGIT-Model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured

Clinical signs:

other: - skin/fur: scales (back), skin yellow (back). Scales and discoloration were observed until termination of the study. - No systemic symptoms were observed in the animals during the study.

Gross pathology:

No macroscopic organ findings were observed in the animals.

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of FAT 40400/A was estimated to be >2000 mg/kg bw.

Executive summary:

In a GLP-compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered FAT 40400/A at the dose of 2000 mg/kg bw. The test substance was dissolved in water and applied on the skin with a syringe and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Scales and discoloration were observed until termination of the study. No macroscopic findings were noted. Therefore, the acute dermal median lethal dose (LD50) of FAT 40400/A was estimated to be >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:

GLP-compliant guideline study, Klimisch code 1

Justification for classification or non-classification

Based on the observed LD₅₀ of >2000 mg/kg bw in the acute oral and dermal toxicity study, 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.