N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide

Endpoint summary

Description of key information

The acute oral toxicity (LD50) in male and female rats was found to be greater than 2000 mg/kg body weight.

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:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: 11 weeks
- Fasting period before study: Fasted for approximately 17 to 18 hours
- Housing: In groups of three in Makroion type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 23/07 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark, music during the daytime light period.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight

Statistics:

None

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Red stained feces and urine were observed in all treated animals at the 5-hour reading or on test day 2. This symptom persisted up to test day 2 or 3 in the six treated females. Otherwise, no clinical signs were observed in any animal at any observation.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 36034/G is greater than 2000 mg/kg bw.

Executive summary:

Acute oral toxicity was conducted with FAT 36034/G following OECD 423 guideline in female Wistar rats observed over a period of 14 days. No mortality was found during the study period. However, red stained feces and urine were observed in all treated animals at the 5-hour reading or on test day 2. This symptom persisted up to test day 2 or 3 in the six treated females. Otherwise, no clinical signs were observed in any animal at any observation. So, the median lethal dose (LD50) of FAT 36034/G 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 study

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

Oral:

A key study was conducted to determine the acute oral toxicity of FAT 36034/G in albino rats according to OECD guideline 423. No mortality was found during the study period. However, red stained feces and urine were observed in all treated animals at the 5-hour reading or on test day 2. This symptom persisted up to test day 2 or 3 in the six treated females. Otherwise, no clinical signs were observed in any animal at any observation. The median lethal dose (LD50) of FAT 36034/G after single oral administration to female rats, observed over a period of 14 days was found to be greater than 2000 mg/kg body weight.

Another study (1993) conducted according to OECD 401, 92/69/EEC, B.l . adopted February 24, 1987. Upon oral administration and a 14 day post-treatment observation period, LD50 in male and female rats for FAT 36034/D was determined to be greater than 2000 mg/kg body weight.

Based on the various study results the acute oral LD50 for FAT 36034 in rats was considered to be greater than 2000 mg/kg.

Inhalation:

Currently no study to assess the acute inhalation toxicity potential of Disperse Red 86:1 is available. However, the vapour pressure for the substance can be considered low (3.69E-11Pa at 25 °C). Hence the substance is considered to have low volatility. 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 and 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 considered to be unlikely. Further the chemical was found to have low acute toxicity when tested via oral route with no mortality when tested upto 2000 mg/kg bw. Hence, considering all the above arguments, it is considered that Disperse Red 86:1 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.

Dermal:

Currently no study to assess acute dermal toxicity of Disperse Red 86:1 is available. However, the molecular weight of the chemical is 408.43 g/mol, indicating it being large for dermal absorption. Hence, the dermal uptake for the chemical is expected to be limited. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD₅₀>2000 mg/kg bw), with no mortality or systemic toxicity being seen upto 2000 mg/kg bw, hence it does not need to be classified STOT SE. Similarly, absence of systemic toxicity in skin irritation studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Hence, low toxicity is expected on acute dermal exposure of Disperse Red 86:1 and testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

Disperse Red 86:1 was considered to be not toxic for acute exposure based on the available information, hence it does not warrant classification for acute toxicity as per the criteria of Regulation (EC) No. 1272/2008.