Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]

Endpoint summary

Description of key information

 oral acute toxicity:
 LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture)
 dermal acute toxicity:
 LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture). Read across was done to hexasodium 2,2'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-morpholin-4-yl-1,3,5-triazine-4,2-diyl)imino]}dibenzene-1,4-disulfonate, CAS 52301-70-9

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:

1994-10-25 and 1994-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-conform study, method according to OECD guideline 401 and method B1 of Commission Directive 92/69/EEC, 49% mixture was tested

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, U.K.
- Age at study initiation: approx. 5 to 8 weeks
- Weight at study initiation: males 150 - 160 g, females 148 - 166 g
- Fasting period before study: overnight fast immediately before dosing, approx. 2 h after dosing
- Housing: housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: rat and mouse expanded diet no. 1, special diets services limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

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: observations: 1/2, 1, 2 and 4 hours after dosing, subsequently once daily; weighing: before experiment, on day 7 and 14
- range-finding study was performed to define the dose level for the main study
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight

Statistics:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

act. ingr.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systematic toxicity were noted during the study. Dark red staining of the fur was noted in all males from 1-hour observation to the day 1 observation, and in one female at the 4-hour and 1 day observations.

Gross pathology:

No abnormalities were noted at necroscopy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP-conform and guideline study

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable method. For justification of read across please refer to IUCLID5 section 13.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

other: Gelbsilber

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean: 2222 g
- Housing: single

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14

Type of coverage:

occlusive

Vehicle:

other: gum arabic

Details on dermal exposure:

TEST SITE
- Area of exposure: 200 - 300 square cm
- Type of wrap: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: with luke warm water and sponge
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2.5 mL/kg
- Concentration: 80 %
- Constant volume or concentration used: yes
- For solids, paste formed: no data

VEHICLE
- Concentration: 1%

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: weighing after 8 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: day 1 to day 8: no resorptive symptoms day 1: Erythema in 4/6 rabbits day 2 to 6: no abnormalities detected in 6/6 animals day 8: scaling found at 1/6 animal

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Scientifically acceptable method.

Additional information

Acute oral toxicity

An acute oral toxicity study (key study) was perfomed by using Sprague-Drawley strain rats. Based on the results of the range-finding study, the test substance (49% act. integr.) was administered by gavage to 5 animals per 5 sex in doses of 2000 mg/kg bw. The animals were observed for mortality and signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The results indicated no deaths. No signs of systemic toxicity were noted during the study. Dark red staining of the fur was noted in all males from the 1 -hour observation to the day 1 observation, and in one female at the 4 -hour and 1 day observations. Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14. All animals showed expected gain in bodyweight during the study. No abnormalities were noted necropsy. The acute oral LD50 of the test material in rats was found to be greater than 2000 mg/kg bw. Since no deaths, no signs of systemic toxicity, normal bw gain, no abnormalities at necropsy were observed in the oral acute toxicity key study with the 49% mixture, the LD50 for the pure substance is also expected to be greater than 2000 mg/kg bw.

Acute dermal toxicity

An acute dermal toxicity study was performed by using yellow-silver rabbits similar to the OECD guideline 402. 3 males and 3 females were treated with the read across substance hexasodium 2,2'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-morpholin-4-yl-1,3,5-triazine-4,2-diyl)imino]}dibenzene-1,4-disulfonate (CAS 52301-70-9; 73.4% act. ingr.) for 24 hours by using an occlusive dressing. Erythema were noted in 4 of 6 animals at the 24 -hours observation. Scuffing was observed on day 7 and 8 after the application. The acute dermal LD50 of the read across substance in rabbits was found to be greater than 2000 mg/kg bw. Since no deaths and normal bw gain was observed, the LD50 for the pure substance is also expected to be greater than 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
One reliable study available.

Justification for selection of acute toxicity – dermal endpoint
One reliable study available.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.