Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt

Endpoint summary

Description of key information

The acute oral median lethal dose (LD50) of FAT 20085/A in rats (both sexes) is greater than 5000 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:

June 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

A single dose was administered to rats by oral gavage and observed for mortality for 14 days observation period.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Healthy Sprague-Dawley derived rats, bred on the premises, aged 5 - 6 weeks, having an average body weight of 167 g (Males) and 125 g (Females).

Husbandry:
Rats were caged singly and kept in a room maintained at a temperature of 21 °C (+/-2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Administration of Compound:
A 25 % w/v suspension of the compound in a 2 % aqueous solution of Carboxymethyl Cellulose was administered as a single dose by gavage to rats which had been fasted for 10 hours, at a dose rate of 20ml/kg. (Equivalent to 5 g/kg compound).

Doses:

20 ml/kg (equivalent to 5 g/kg compound).

No. of animals per sex per dose:

Ten rats (5 males and 5 females).

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ examinations.

Statistics:

None

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the 14 days observation period.

Clinical signs:

other: No clinical symptoms were recorded during the 14 days observation period.

Gross pathology:

At autopsy no changes in organs or tissues causes by the administration of the test compound were seen.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 20085/A in rats (both sexes) is >5000 mg/kg body weight.

Executive summary:

The acute oral toxicity of FAT 20085/A was evaluated in a study conducted according to the methodology similar to OECD Guideline 401. In this study, the test article FAT 20085/A was administered as a single dose by oral gavage to rats of both sexes, at a dose of 5000 mg/kg bw in a solution of Carboxymethyl Cellulose. No deaths or clinical signs were observed during the 14-days observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. Hence, the acute oral toxicity (LD50) of FAT 20085/A in rats of both sexes, observed over a period of 14 days, was estimated to be >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:

Guideline study with acceptable restrictions.

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

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral:

The acute oral toxicity of FAT 20085/A was evaluated in a study conducted according to the methodology similar to OECD Guideline 401. In this study, the test article FAT 20085/A was administered as a single dose by oral gavage to rats of both sexes, at a dose of 5000 mg/kg bw in a solution of Carboxymethyl Cellulose. No deaths or clinical signs were observed during the 14-days observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. Hence, the acute oral toxicity (LD50) of FAT 20085/A in rats of both sexes, observed over a period of 14 days, was estimated to be >5000 mg/kg bw.

Inhalation:

Currently no study to assess the acute inhalation toxicity potential of ACID BLUE 090 is available. The vapour pressure forthe substance was determined to be 9.34x10E-2 Pa. Hence the substance is considered to have low volatility. Owing to this, 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. The water solubility of ACID BLUE 090 was determined to be 171 g/L,hence the dust if inhaled may be retained within the mucus, thereby further limiting the reach to the lower respiratory tract. Further, no systemic toxicity or mortality were observed in the acute oral toxicity studies withACID BLUE 090. Taking into consideration above information, acute inhalation exposure is considered to have negligible potential for systemic toxicity. Therefore testing by the inhalation route was considered scientifically not necessary and the intrinsic property/toxicity potential can be extrapolated from the acute oral toxicity study.

Dermal:

Currently no study to assess acute dermal toxicity of ACID BLUE 090 is available. However, the molecular weight of the substance is 854 g/mol, which indicates substance is too large for dermal absorption. Further, owing to high water solubility (171 g/L) and low partition coefficient (-2.55), the substance is considered to be too hydrophilic to cross the lipid rich environment of the stratum corneum and hence the dermal uptake for the substance is expected to be low. Further, no systemic toxicity or mortality were observed in the acute oral toxicity study with ACID BLUE 090. Hence, potential for occurrence of systemic toxic effects subsequent to dermal exposure is considered to be unlikely to occur. 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 exposure. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the substance 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

Acid Blue 090 was found to be not acute toxic up to the dose 2000 mg/kg bw, hence it does not warrant classification as per the criteria of Regulation (EC) No. 1272/2008 (CLP).