Reaction mass of Disodium dihydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(2-) and Sodium hydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(1-)

Endpoint summary

Description of key information

The acute oral LD50 of ACID YELLOW 104 in rats of both sexes observed over a period of 14 days was found to be 6213 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:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

None

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Sex: male/female
- Housing: housed in groups of 5 in Macrolon cages (type 3),
- Diet: rat food (NAFAG, Gossau SG) ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 55±10 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day.

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

None

Doses:

2000, 3000, 4000, 5000, 7000 and 9000 mg/kg bw
10 and 20 ml/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

None- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 including 95 % confidence limits were calculated by the logit model.

Preliminary study:

None

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 9 000 mg/kg bw

Based on:

test mat.

Mortality:

Following mortality was observed: 2 females at 3000 mg/kg bw and 1 female each at 4000 and 5000 mg/kg bw

Clinical signs:

Dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position were observed. The surviving animals recovered within 8 to 9 days.

Body weight:

No adverse effects on body weight changes were seen.

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of compound FAT 20041/B in rats is >9000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 20041/B was evaluated using a methodology that was similar to OECD Guideline 401. After administration of the compound at 2000, 3000, 4000, 5000, 7000 and 9000 mg/kg bw, the groups (5 male and 5 females in each group) of rats were observed for 14 days. Following mortality was observed: 2 females at 3000 mg/kg bw and 1 female each at 4000 and 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position were observed. The surviving animals recovered within 8 to 9 days. No adverse effects on body weight changes were seen. At autopsy no changes caused by the administration of FAT 20041/B were seen. In conclusion, the acute oral LD50 of FAT 20041/B in rats of both sexes observed over a period of 14 days is concluded to be >9000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 213 mg/kg bw

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 toxicity:

ACID YELLOW 104 was evaluated in two studies conducted according to the methodology that was similar to the one described in OECD Guideline 401.

In the study designated as key, groups of rats (5 males and 5 females in each group) were administered FAT 20041/A at 2150, 3590, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 days. Following adminstration of the test substance, mortalities recorded were as follows: 1 male at 3590 mg/kg bw, 2 females at 4640 mg/kg bw, 1 male and 1 female at 6000 mg/kg bw, 3 males and 5 females at 7750 mg/kg bw, 5 males and 5 females at 10000 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. At autopsy no changes caused by the administration of FAT 20041/A were seen with found dead as well as surviving animals.In conclusion, the acute oral LD50 of FAT 20041/A in rats of both sexes observed over a period of 14 days is 6213 mg/kg bw.

In the second study, the groups (5 male and 5 females in each group) of rats were observed for 14 days following administration of FAT 20041/B at 2000, 3000, 4000, 5000, 7000 and 9000 mg/kg bw. Following mortality was observed: 2 females at 3000 mg/kg bw and 1 female each at 4000 and 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position were observed. The surviving animals recovered within 8 to 9 days. No adverse effects on body weight changes were seen. At autopsy no changes caused by the administration of FAT 20041/B were seen.In conclusion, the acute oral LD50 of FAT 20041/B in rats of both sexes observed over a period of 14 days is concluded to be >9000 mg/kg bw.

Acute inhalation toxicity:

Currently no study to assess acute inhalation toxicity potential of ACID YELLOW 104 is available.However, the substance is considered to have low volatility as the melting point is >350 °C. ACID YELLOW has high water solubility of 366 g/L, indicating if dust is produced/inhaled, will be trapped in the mucus and transferred to the GI tract by mucociliary clearance or coughed up.The median particle size of 47.77 µm indicates that the major part of the test substance will not be able to reachalveolar region of the respiratory tract.Further the substance was found to have low toxicity (LD50 = 6213 mg/kg bw) when tested in acute oral toxicity studies, thus indicating low toxicity on acute exposure. Taking into account the above arguments, ACID YELLOW 104 is considered to have low toxicity on acute inhalation exposure. Hence, the study is considered scientifically not necessary.

 

Acute dermal toxicity:

Currently no study to assess acute dermal toxicity potential of ACID YELLOW 104 is available. However, the molecular weight of the substance ranges from 491.35 – 531.35 g/mol, which indicates substance is partcularly large for dermal absorption. Further, high water solubility (399.9 g/L) and low partition coefficient (log Pow = -4.75), 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. The substance showed low toxicity potential in the available acute oral toxicity studies (LD₅₀= 6213 mg/kg bw). Similarly absence of systemic toxicity or mortality in skin irritation as well as sensitization studies, further 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 taken into account.

Justification for classification or non-classification

Based on the available data from acute toxicity studies, ACID YELLOW 104 does not meet the criteria of classification for acute toxicity according to the CLP (1272/2008) Regulation.